Medical injector with compliance tracking and monitoring

ABSTRACT

A system includes a medicament delivery device and a container configured to receive at least a portion of the medicament delivery device. The medicament delivery device includes an actuator and a first electronic circuit system. The actuator is configured to initiate delivery of a medicament into a body when the actuator is moved from a first position to a second position. The first electronic circuit system is configured to output a first electronic signal when the actuator is moved from the first position to the second position. The container includes a second electronic circuit system configured to receive the first electronic signal. The second electronic circuit system is configured to output a second electronic signal associated with the first electronic signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/017,405, entitled “Medical Injector With Compliance Tracking andMonitoring,” filed Jan. 22, 2008, which is a continuation-in-part ofU.S. patent application Ser. No. 11/671,025, now U.S. Pat. No.8,172,082, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 5, 2007, which is a continuation-in-part of U.S.patent application Ser. No. 11/621,236, now U.S. Pat. No. 7,731,686,entitled “Devices, Systems and Methods for Medicament Delivery,” filedJan. 9, 2007, which is a continuation-in-part of U.S. patent applicationSer. No. 10/572,148, now U.S. Pat. No. 7,749,194, entitled “Devices,Systems and Methods for Medicament Delivery,” filed Mar. 16, 2006, whichis a national stage filing under 35 U.S.C. §371 of International PatentApplication No. PCT/US2006/003415, entitled “Devices, Systems andMethods for Medicament Delivery,” filed Feb. 1, 2006, which claimspriority to U.S. Provisional Application Ser. No. 60/648,822, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1,2005 and U.S. Provisional Application Ser. No. 60/731,886, entitled“Auto-Injector with Feedback,” filed Oct. 31, 2005; each of which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 12/017,405 also claims priority to U.S. ProvisionalApplication Ser. No. 60/885,969, entitled “Medicament Delivery Deviceswith Wireless Communication,” filed Jan. 22, 2007, which is incorporatedherein by reference in its entirety. U.S. patent application Ser. Nos.11/671,025 and 11/621,236 each claim priority to U.S. ProvisionalApplication Ser. No. 60/787,046, entitled “Devices, Systems and Methodsfor Medicament Delivery,” filed Mar. 29, 2006, which is incorporatedherein by reference in its entirety.

BACKGROUND

The invention relates generally to medical devices, and moreparticularly to medical systems, medicament delivery devices and methodsfor delivering a medicament into a body of a patient and outputting anelectronic signal in response to such delivery.

Self-administered medicament delivery devices, such as, for examplepre-filled medical injectors, inhalers, transdermal delivery devices andthe like are often used as a part of a patient's medication regimen. Forexample, known self-administered medicament delivery devices can be usedas a part of a patient's emergency care regimen. Emergency care regimenscan include, for example, using an auto-injector to rapidlyself-administer a medicament in response to an allergic reaction or forthe treatment of other emergency conditions (e.g., nerve-agent poisoningon the battlefield). Known self-administered medicament delivery devicescan also be used as a part of a patient's chronic care regimen. Chroniccare regimens can include, for example, using a pen injector toself-administer a medicament according to a prescribed plan. Examples ofchronic care regimens can include, for example, the injection ofinsulin, the injection of human growth hormone (HGH),erythropoiesis-stimulating agents (ESA), DeMab, Interferons and otherchronic therapies, or the like. Furthermore, self-administeredmedicament delivery devices can also be used for preventive/prophylactictherapies. Examples of preventive/prophylactic therapies include certainvaccines, such as an influenza vaccine.

In the pharmaceutical industry, it can be important to understandpatient compliance with self-administered medicament delivery devices.Patient compliance can include any measure of a patient's conformance toa particular therapeutic drug delivery regimen or other indication asmandated by a health care provider or pharmaceutical manufacturer. Moreparticularly, patient compliance measures can include the location wherethe device was activated, time of day, dose regimen, dosage and route ofadministration, frequency of device usage, functionality of the deviceonce used, expiration date of the device, device status, medicamentstatus, and any adverse event experienced by the user following the useof the device. Patient compliance can also include providingcommunication to the patient regarding their therapy (e.g., anotification of when to take their medication, etc.). Understandingpatient compliance with medicament delivery devices can enhance theability of a health care provider to effectively manage a patient'smedication regimen, which can lead to improved patient outcomes. Patientcompliance data can also be used to inform the manufacturer of thedevice about potential issues with the device (e.g., data demonstratingpoor compliance with a particular device may trigger a manufacturer toinvestigate the cause of poor compliance and/or change the design orfunctionality of the device to improve patient care and outcome), alertemergency contacts (including family members, patient guardians, andindividuals with Power of Attorney privileges), and aid the patient withadhering to their prescribed therapy. Increasing patient compliance canalso generate considerable cost savings for health care providers,pharmaceutical benefits managers (PBM), specialty pharmacies, clinicaltrial administrators, insurance companies and/or payors.

Ensuring patient compliance with some known medicament delivery devicescan be problematic. For example, some known medicament delivery devices(e.g., emergency care devices, as described above and/or chronic caredevices) can be bulky and conspicuous, which can make carrying theminconvenient and undesirable. Accordingly, the patient may not carry themedicament delivery device at all times, resulting in the failure to usethe medicament delivery device as prescribed.

Similarly, to actuate some known medicament delivery devices, the usermay be required to execute a series of operations. For example, toactuate some known auto-injectors, the user must remove a protectivecap, remove a locking device, place the auto-injector in a properposition against the body and then press a button to actuate theauto-injector. Failure to complete these operations properly can resultin an incomplete injection and/or injection into an undesired locationof the body.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices often can be used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic and/or the physiological effects ofthe condition requiring treatment.

Monitoring the patient's compliance with known medicament deliverydevices can also be problematic. For example, some known medicamentdelivery systems include a medicament delivery device and an electronicsystem to assist the user in setting the proper dosage and/ormaintaining a compliance log. Such known medicament delivery systems andthe accompanying electronic systems can be large and therefore notconveniently carried by the user. Such known medicament delivery systemsand the accompanying electronic systems can also be complicated to useand/or expensive to manufacture.

Thus, a need exists for medicament delivery systems and/or devices thatcan provide compliance information associated with the use of thedevice. Moreover, a need exists for medicament delivery systems and/ordevices that can communicate electronically with other communicationsdevices.

SUMMARY

Medicament delivery systems and devices are described herein. In someembodiments, a system includes a medicament delivery device and acontainer configured to receive at least a portion of the medicamentdelivery device. The medicament delivery device includes an actuator anda first electronic circuit system. The actuator is configured toinitiate delivery of a medicament into a body when the actuator is movedfrom a first position to a second position. The first electronic circuitsystem is configured to output a first electronic signal when theactuator is moved from the first position to the second position. Thecontainer includes a second electronic circuit system configured toreceive the first electronic signal. The second electronic circuitsystem is configured to output a second electronic signal associatedwith the first electronic signal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an auto-injector according to anembodiment of the invention.

FIG. 2 is a front cross-sectional view of the auto-injector shown inFIG. 1.

FIG. 3 is a schematic illustration of a portion of the auto-injectorshown in FIG. 1.

FIG. 4 is a schematic illustration of a medicament delivery deviceaccording to an embodiment of the invention.

FIG. 5 is a perspective view of an auto-injector according to anembodiment of the invention.

FIG. 6 is a front view of the auto-injector illustrated in FIG. 5, witha portion of the auto-injector illustrated in phantom lines for ease ofreference.

FIG. 7 is a partial cut-away front view of a portion of theauto-injector illustrated in FIG. 5.

FIG. 8 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 8-8 in FIG. 7.

FIG. 9 is a cross-sectional view of a portion of the auto-injectorillustrated in FIG. 5 taken along line 9-9 in FIG. 7.

FIG. 10 is a front view of a portion of the auto-injector illustrated inFIG. 5.

FIG. 11 is a schematic illustration of a portion of the auto-injectorillustrated in FIG. 5.

FIG. 12 is a perspective view of a portion of the auto-injectorillustrated in FIG. 5 in a second configuration.

FIG. 13 is a front plan view of a portion of the auto-injectorillustrated in FIG. 5 in a third configuration.

FIG. 14 is a front plan view of a portion of the auto-injectorillustrated in FIG. 5 in a fourth configuration.

FIGS. 15 and 16 are front plan views of a portion of the auto-injectorlabeled as region 15 in FIG. 10, in a first configuration and a secondconfiguration, respectively.

FIGS. 17 and 18 are perspective views of an inhaler according to anembodiment of the invention, in a first configuration and a secondconfiguration, respectively.

FIG. 19 is a schematic illustration of a medicament delivery deviceaccording an embodiment of the invention.

FIGS. 20-22 are schematic illustrations of a medical system according toan embodiment of the invention, in a first configuration, a secondconfiguration and a third configuration, respectively.

FIG. 23 is a flow chart of a method according to an embodiment of theinvention.

FIGS. 24-27 are perspective views of a medical system according to anembodiment of the invention, in a first configuration, a secondconfiguration, a third configuration, and a fourth configuration,respectively.

FIG. 28 is a schematic illustration of a medical system according to anembodiment of the invention.

FIGS. 29-31 are perspective views of a medical system according to anembodiment of the invention, in a first configuration, a secondconfiguration, and a third configuration, respectively.

FIGS. 32 and 33 are schematic illustrations of a medicament deliverydevice according to an embodiment of the invention, in a firstconfiguration and a second configuration, respectively.

FIGS. 34 and 35 are schematic illustrations of a medicament deliverydevice according to an embodiment of the invention, in a firstconfiguration and a second configuration, respectively.

FIG. 36 is a schematic illustration of a medicament delivery deviceaccording an embodiment of the invention.

FIG. 37 is a schematic illustration of a medicament delivery deviceaccording an embodiment of the invention.

FIG. 38 is a schematic illustration of a medicament delivery deviceaccording an embodiment of the invention.

FIG. 39 is a schematic illustration of a medicament delivery deviceaccording an embodiment of the invention.

DETAILED DESCRIPTION

In some embodiments, a system includes a medicament delivery device anda container configured to receive at least a portion of the medicamentdelivery device. The medicament delivery device, which can be, forexample, a single-use medical injector, includes an actuator and a firstelectronic circuit system. The actuator is configured to initiatedelivery of a medicament into a body when the actuator is moved from afirst position to a second position. The first electronic circuit systemis configured to output a first electronic signal when the actuator ismoved from the first position to the second position. The firstelectronic signal can be, for example, a short-range radio frequencysignal having a range of approximately 100 meters or less. The containerincludes a second electronic circuit system configured to receive thefirst electronic signal. The second electronic circuit system isconfigured to output a second electronic signal associated with thefirst electronic signal.

In some embodiments, an apparatus includes a medicament delivery deviceand an electronic circuit system coupled to the medicament deliverydevice. The medicament delivery device includes an actuator configuredto initiate delivery of a medicament into a body when the actuator ismoved from a first position to a second position. The electronic circuitsystem includes a first radio frequency identification tag configured tooutput a first electronic signal and a second radio frequencyidentification tag configured to output a second electronic signal. Thesecond electronic signal has a characteristic (e.g., a frequency)different than a characteristic of the first electronic signal. Theactuator is configured to prevent the second radio frequencyidentification tag from outputting the second electronic signal when theactuator is moved from the first position to the second position. Insome embodiments, for example, the actuator is configured to sever atleast a portion of the second radio frequency identification tag whenthe actuator is moved from the first position to the second position.

In some embodiments, an apparatus includes a housing, a medicamentcontainer disposed within the housing, a needle, and an electroniccircuit system. The needle has a proximal end and a distal end, and isconfigured to be in fluid communication with the medicament container.The needle is configured to be moved between a first position and asecond position. The distal end of the needle is disposed within thehousing when the needle is in the first position. At least a portion ofthe distal end of the needle is disposed outside of the housing when theneedle is in the second position. The electronic circuit system isconfigured to be coupled to the housing. The electronic circuit systemis configured to output an electronic signal associated with animpedance between the distal end of the needle and a portion of thehousing.

In some embodiments, a method includes moving an actuator of amedicament delivery device to initiate delivery of a medicament into abody. The actuator can be, for example, a mechanical actuator configuredto release a spring, an energy storage member, or the like to initiatemedicament delivery when the actuator is moved from the first positionto the second position. A first electronic signal is output from a firstelectronic circuit system in response to the movement of the actuatorbetween the first position and the second position. The first electronicsignal is a short-range radio frequency signal having a range ofapproximately 100 meters or less. A second electronic signal associatedwith the first electronic signal is output from a second electroniccircuit system.

As used herein, the term “regimen” or “medication regimen” can includeany program, schedule and/or procedure to enhance, improve, sustain,alter, and/or maintain a patient's well-being. A regimen can include,for example, a schedule of medicament delivery events (e.g., injections,oral doses, etc.) that are prescribed or otherwise suggested for thepatient. For example, a regimen can include daily insulin injections. Aregimen can also include a single medicament delivery event that can beprescribed or otherwise suggested for the patient to administer inresponse to given a set of circumstances. For example, a regimen caninclude a injection of epinephrine in response to an allergic reaction.A regimen can also include the delivery of a placebo or inactiveingredient. For example, a clinical trial can include a regimenincluding various injections of a placebo. Finally, a regimen can alsoinclude activities other than the delivery of drugs to the patient. Forexample, a regimen can include certain procedures to be followed toenhance the patient's well-being (e.g., a schedule of rest, a dietaryplan, etc.).

FIGS. 1 and 2 are a perspective view and a partial cutaway front view,respectively, of an auto-injector 1002 according to an embodiment of theinvention. The auto-injector 1002 is similar to the auto-injectorsdescribed in U.S. patent application Ser. No. 11/562,061, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Nov. 21,2006, which is incorporated herein by reference in its entirety.Accordingly, only an overview of the mechanical components and relatedoperation of the auto-injector 1002 is included below.

The auto-injector 1002 includes a housing 1110 that defines a gaschamber 1120. The housing 1110 has a proximal end portion 1112 and adistal end portion 1114. A base 1520 is movably coupled to the distalend portion 1114 of the housing 1110. A safety lock 1710 is removablycoupled to the base 1520. As discussed in more detail herein, when thesafety lock 1710 is coupled to the base 1520, the auto-injector 1002cannot be actuated. When the safety lock 1710 is removed from the base1520, the base 1520 can be moved relative to the housing 1110, therebyactuating the auto-injector 1002. Accordingly, to inject a medicamentinto the body, the distal end portion 1114 of the housing 1110 isoriented towards the user such that the base 1520 is in contact with theportion of the body where the injection is to be made. The base 1520 isthen moved towards the proximal end 1112 of the housing 1110 to actuatethe auto-injector 1002.

The auto-injector 1002 includes a medicament injector 1210 and a systemactuator 1510 disposed non-coaxially within the housing 1110. Themedicament injector 1210 includes multiple medicament vials 1262, aplunger 1284 movably disposed within each medicament vial 1262, amovable member 1312 engaged with each plunger 1284 and a needle 1212.Retraction springs 1350 located within a portion of the base 1520 andthe housing 1110 can push the needle 1212 back within the housing 1110after injection. The system actuator 1510 includes a compressed spring1560, a compressed gas cylinder 1412, and a puncturing mechanism 1612 todispel the contents of the compressed gas cylinder 1412.

In use, when the auto-injector 1002 is actuated, the puncturingmechanism 1612 punctures the compressed gas cylinder 1412 allowing apressurized gas to flow into the gas chamber 1120. In response to aforce produced by the pressurized gas on the movable member 1312, themovable member 1312 moves distally within the housing 1110. As a result,the needle 1212 is extended through the housing 1110. The movement ofthe movable member 1312 also causes the plungers 1284 to move within thevials 1262, thereby expelling a medicament from the vials 1262.

The auto-injector 1002 includes an electronic circuit system 1920configured to provide a predetermined sequence of electronic outputsand/or electronic signals during the use of the auto-injector 1002. Theelectronic circuit system 1920 is powered by a battery (not shown inFIGS. 1 and 2) and includes a processor (see e.g., FIG. 3), a startbutton 1970, two switches 1972A and 1972B, a proximity sensor 1974, twovisual output devices 1958A and 1958B, an audio output device 1956, anda network interface device 1953. The components of the electroniccircuit system 1920 are operatively coupled by any suitable mechanism,such as, for example, a printed circuit board (not shown in FIGS. 1 and2) having conductive traces.

The start button 1970 is disposed on the proximal end of the housing1110 and can be manually actuated by the user to begin the sequence ofelectronic outputs. The first switch 1972A is disposed on the distalportion 1114 of the housing 1110 adjacent the base 1520 and the lockingmember 1710. The locking member 1710 is configured to engage the firstswitch 1972A such that when the locking member 1710 is removed, as shownin FIG. 1, the first switch 1972A changes states. In this manner,removal of the locking member 1710 can trigger the processor to output apredetermined electronic output. Said another way, the electroniccircuit system 1920 can produce and/or output an electronic signaland/or an electronic output when the auto-injector 1002 is moved from a“storage” configuration (i.e., a configuration in which the lockingmember 1710 will prevent the actuation of the auto-injector 1002) to a“ready” configuration (i.e., a configuration in which the auto-injector1002 can be actuated).

The proximity sensor 1974 is disposed on the base 1520 and is configuredto produce an output when the base 1520 engages the body. The proximitysensor can be, for example, a temperature sensor, an optical sensor,pressure sensor, impedance sensor or the like. In this manner, theprocessor can be prompted to output a predetermined electronic outputwhen the base 1520 is positioned against the body.

Similarly, the second switch 1972B is disposed on the housing 1110adjacent the medicament injector 1210. The medicament injector 1210 isconfigured to engage the second switch 1972B such that when themedicament injector 1210 is moved distally within the housing 1110 thesecond switch 1972B changes states. In this manner, the processor can beprompted to output a predetermined electronic output based on theposition of the medicament injector 1210. Said another way, theelectronic circuit system 1920 can produce and/or output an electronicsignal and/or an electronic output in response to the actuation of theauto-injector 1002.

In some embodiments, the electronic circuit system 1920 can beconfigured to output an electronic signal and/or an electronic outputbased on the output of the proximity sensor 1974 and the output from thesecond switch 1972B. For example, in some embodiments, the electroniccircuit system 1920 can output a first electronic signal when the outputfrom the proximity sensor 1974 indicates that the base 1520 of theauto-injector 1002 is in contact with the body when the second switch1972B changes states, and a second electronic signal when the outputfrom the proximity sensor 1974 indicates that the base 1520 of theauto-injector 1002 is disposed apart from the body when the secondswitch 1972B changes states. Said another way, in some embodiments, theelectronic circuit system 1920 can be configured to output a firstelectronic signal associated with the occurrence of a valid injectionevent (i.e., an injection event during which there was a high likelihoodthat the medicament was properly injected into the body) and a secondelectronic signal associated with the occurrence of an invalid injectionevent (i.e., an injection event during which there was a high likelihoodthat the medicament was not injected into the body).

The first visual output device 1958A is disposed on the locking member1710. Similarly, the second visual output device 1958B is disposed onthe outer surface 1111 of the housing 1110. The visual output devices1958A and 1958B are in electronic communication with the processor andare configured to produce an output in response to an electronic signaloutput by the processor. The visual output devices 1958A and 1958B, aswell as any other visual output devices referenced herein, can be anysuitable visual indicia, such as, light-emitting diodes (LEDs),liquid-crystal display (LCD) screens, optical polymers, fiber opticcomponents or the like. In some embodiments, the visual output devices1958A and 1958B can be coupled to the housing 1110 and/or the lockingmember 1710 by a label 1910.

The audio output device 1956 is disposed within the housing 1110 suchthat it can project sound outside of the housing 1110. The audio outputdevice 1956, as well as any other audio output devices referencedherein, can be any suitable device for producing sound, such as amicro-speaker a piezo-electric transducer or the like. Such sound outputcan include, for example, an alarm, a series of beeps, recorded speechor the like. The audio output device 1956 is in electronic communicationwith the processor and is configured to produce an output in response toan electronic signal output by the processor.

The network interface device 1953 is configured to operatively connectthe electronic circuit system 1920 to a remote device 1941 (see FIG. 3)and/or a communications network (not shown in FIGS. 1-3). In thismanner, the electronic circuit system 1920 can send information toand/or receive information from the remote device 1941. The remotedevice 1941 can be, for example, a remote communications network, acomputer, a compliance monitoring device, a cell phone, a personaldigital assistant (PDA) or the like. Such an arrangement can be used,for example, to download replacement processor-readable code 1955 (seeFIG. 3) from a central network to the memory device 1954 (see FIG. 3).In some embodiments, for example, the electronic circuit system 1920 candownload information associated with a medicament delivery device 1002,such as an expiration date, a recall notice, updated use instructions orthe like. Similarly, in some embodiments, the electronic circuit system1920 can upload compliance information associated with the use of themedicament delivery device 1002 via the network interface device 1953.

In use, the user activates the electronic circuit system by pushing thestart button 1970 to activate the processor, thereby causing theprocessor to output a predetermined sequence of electronic outputs. Insome embodiments, the start button 1970 can activate the processor byproviding an input to the processor. In other embodiments, the startbutton 1970 can activate the processor by placing the battery (not shownin FIGS. 1 and 2) in electronic communication with the processor.

In some embodiments, upon activation, the processor can output anelectronic signal to the audio output device 1956 thereby producing afirst electronic output instructing the user in how to use theauto-injector 1002. Such a message can state, for example, “pleaseremove the safety tab.” Additionally, the first visual output device1958A can produce a flashing light to further indicate to the user wherethe locking member 1710 is located. The processor can be configured torepeat the first audible instruction if the locking member 1710 is notremoved within a predetermined time period.

When the user removes the locking member 1710, the first switch 1972Achanges states thereby triggering the processor to output an electronicoutput providing a second instruction to the user. The secondinstruction can be, for example, an audible speech output instructingthe user to “please place the base of the device on the outer portion ofyour thigh.” The first visual output device 1958A can produce a lightedoutput during this audible instruction, thereby visually indicatingwhere the base 1520 is located and/or what portion of the base 1520should be placed on the thigh.

When the user places the base 1520 against the body, the proximitysensor 1974 provides an input to the processor, thereby triggering theprocessor to output an electronic output providing a third instructionto the user. The third instruction can be, for example, an audiblespeech output instructing the user to “push down on the top of thedevice to activate the injector.”

When the injection is completed, the medicament injector 1210 isconfigured to engage the second switch 1972B, thereby triggering theprocessor to output an electronic output providing a fourth instructionto the user. Such a post-use instruction can be, for example, an audiblespeech output instructing the user to seek further medical attention,providing instructions for the safe disposal of the auto-injector 1002or the like.

In some embodiments, the processor 1950 can output an electrical signalassociated with the second switch 1972B that is received by a remotedevice 1941, which can be, for example, a compliance tracking device.Said another way, in some embodiments, the electronic circuit system1920 can output, to the remote device 1941, an electrical signalassociated with the end of the injection event. In this manner theelectronic circuit system 1920 on the auto-injector 1002 can cooperatewith the remote device 1941 to electronically and/or automatically trackthe details of the use of the auto-injector 1002. Similarly stated, theelectronic circuit system 1920 on the auto-injector 1002 and the remotedevice 1941 can electronically and/or automatically track the patientcompliance data associated with the use of the auto-injector 1002.

FIG. 3 is a schematic illustration of the electronic circuit system 1920of the auto-injector 1002. The electronic circuit system 1920 includes aprocessor 1950 operatively coupled to a memory device 1954. The memorydevice 1954 can be configured to store processor-readable code 1955instructing the processor 1950 to perform the functions described above.In some embodiments, the processor-readable code 1955 can be modifiedand/or updated as circumstances dictate. The electronic circuit system1920 includes an input/output device 1952 configured to receiveelectronic inputs from the switches 1972A and 1972B, the proximitysensor 1974 and/or the start button 1970. The input/output device 1952is also configured to provide electronic signals to the various outputdevices, such as the visual output devices 1958A and 1958B and the audiooutput device 1956.

As described above, the electronic circuit system 1920 also includes anetwork interface 1953 configured to couple the electronic circuitsystem 1920 to a remote device 1941 and/or a communications network (notshown in FIG. 3). Such an arrangement can be used, for example, todownload replacement processor-readable code 1955 from a central network(not shown) to the memory device 1954. The network interface 1953 canalso be configured to transmit information from the electronic circuitsystem 1920 to a central network and/or the remote device 1941 (e.g.,the user's home computer, the user's cell phone or the like). Thenetwork interface 1953 can include any hardware, software and/orfirmware suitable for establishing communication between the electroniccircuit system 1920 and the remote device 1941. For example, in someembodiments, the network interface 1953 can include a microprocessor, atransmitter, a receiver, a transceiver, a microchip, a radio chipset, awireless interface card (WIC), a host controller interface (HCI), auniversal asynchronous receiver/transmitter (UART), a power source(e.g., a battery), one or more sensors, a transponder, an antenna, acrystal, a circuit board, a liquid crystal display (LCD), a SmallComputer System Interface (SCSI and ports), a FireWire (or other IEEE1394 interfaces), a data uplink, a data downlink, a point-to-point link,a fiber optic link, a storage device (e.g., hard drive, flash drive orthe like), a personal computer cards, a docking stations, a paralleland/or bit-serial connections, a Universal Serial Bus (USB) port orother serial ports, radiofrequency identification (RFID) devices and/orother common electronic components used to establish electroniccommunication.

FIG. 4 is a schematic illustration of a medical device 2002 according toan embodiment of the invention. The medical device 2002, which can be,for example, a medicament delivery device such as an auto-injector, apen injector, an inhaler, a transdermal delivery system or the like,includes a housing 2110 and a label 2910. The label 2910 is coupled toan outer surface 2111 of the housing 2110. The label 2910 includes afirst surface 2912, a second surface 2914 and an electronic circuitsystem 2920. The first surface 2912 is configured to engage the outersurface 2111 of the housing 2110 to couple the label 2910 to the housing2110. In some embodiments, the first surface 2912 can include anadhesive to fixedly couple the label 2910 to the housing 2110. Thesecond surface 2914 includes a textual indicia 2916. The textual indicia2916 can include, for example, a description of the medicament deliverydevice, a source of the medicament delivery device and/or an instructionassociated with the use of the medicament delivery device. Although thefirst surface 2912 is shown as being opposite the second surface 2914,in other embodiments, the first surface 2912 and the second surface 2914can be adjacent each other and/or co-planar.

The electronic circuit system 2920 is configured to output an electronicsignal of the types shown and described herein. As discussed in moredetail herein, the electronic circuit system 2920 can include manycomponents, such as, for example, a processor, a switch, a visual outputdevice and/or an audio output device. The electronic signal can be, forexample, an electronic signal communicated to an output device, such as,for example, a visual output device, an audio output device, a hapticoutput device or the like. In some embodiments, the electrical signalcan be a communications signal configured to be received by a remotedevice, in a manner similar to that described herein.

In some embodiments, the electronic signal can be associated with anaspect of the medical device 2002, such as an instruction associatedwith an initial use of the medical device 2002. For example, in someembodiments, the electronic circuit system 2920 can output a textmessage to a display screen (not shown) disposed on the medical device2002 instructing the user in the use of the medical device 2002. Inother embodiments, the electronic circuit system 2920 can produce anaudio output, such as recorded speech, instructing the user in the useof the medical device 2002. In yet other embodiments, the electroniccircuit system 2920 can produce and/or transmit an electrical signalassociated with a medicament delivery event. In this manner, theelectronic circuit system 2920 can be used to track the patientcompliance data associated with the use of the medicament deliverydevice 2002.

Although the electronic circuit system 2920 is shown as being disposedon the second surface 2914 of the label 2910, in other embodiments, theelectronic circuit system can be disposed on the first surface 2912 ofthe label 2910. In yet other embodiments, the electronic circuit system2920 can be disposed between the first surface 2912 and the secondsurface 2914 of the label 2910. In yet other embodiments, the label 2910can include multiple discrete layers coupled together, within whichportions of the electronic circuit system can be disposed.

FIG. 5 is a perspective view of an auto-injector 4002 according to anembodiment of the invention. The auto-injector 4002 is similar to theauto-injectors described in U.S. patent application Ser. No. 11/562,061,entitled “Devices, Systems and Methods for Medicament Delivery,” filedNov. 21, 2006, which is incorporated herein by reference in itsentirety. Accordingly, the mechanical components and operation of theauto-injector 4002 are not described in detail herein.

The auto-injector 4002 includes a housing 4110 having a proximal endportion 4112 and a distal end portion 4114. The distal end portion 4114of the housing 4110 includes a protrusion 4142 to help a user grasp andretain the housing 4110 when using the auto-injector 4002. Said anotherway, the protrusion 4142 is configured to prevent the auto-injector 4002from slipping from the user's grasp during use. A base 4520 is movablycoupled to the distal end portion 4114 of the housing 4110. A needleguard assembly 4810 is removably coupled to the base 4520. Similarly, asafety lock 4710 is removably coupled to the base 4520. To inject amedicament into the body, the distal end portion 4114 of the housing isoriented towards the user such that the base 4520 is in contact with theportion of the body where the injection is to be made. The base 4520 isthen moved towards the proximal end 4112 of the housing 4110 to actuatethe auto-injector 4002.

The auto-injector 4002 includes a label 4910 coupled to an outer surface4111 of the housing 4110. The label 4910 includes an outer layer 4911,an intermediate layer 4980 and an electronic circuit system 4920 (seeFIGS. 7-9). FIG. 6 is a front view of the auto-injector 4002 showing theouter layer 4911 of the label 4910 in phantom lines so that theintermediate layer 4980 and an electronic circuit system 4920 can bemore clearly seen. As shown in FIGS. 7-9, the outer layer 4911, which,in some embodiments, can be constructed from paper, has a first surface4912 and a second surface 4914 opposite the first surface 4912. Multipleindicia 4916 are disposed on the first surface 4912. The indicia 4916include a textual indicia 4916A and two symbolic indicia 4916B. Thetextual indicia 4916B can be written text describing the medicamentdelivery device, indicating a source of the medicament delivery deviceand/or instructing a user in the use of the medicament delivery device.The symbolic indicia 4916B can include, for example, arrows, pointers,trademarks, symbols describing the use of the medicament delivery deviceor the like. The label 4910 is coupled to the outer surface 4111 of thehousing 4110 such that the portion of the first surface 4912 includingthe indicia 4916 is visible.

A portion of the second surface 4914 of the outer layer 4911 can becoupled to the outer surface 4111 of the housing 4110 by any suitablemethod. For example, in some embodiments, the second surface 4914 of theouter layer 4911 includes an adhesive configured to bond the outer layer4911 to the outer surface 4111 of the housing 4110. Other portions ofthe second surface 4914 of the outer layer 4911 are adjacent theintermediate layer 4980 and portions of the electronic circuit system4920. In this manner, the outer layer 4911 of the label 4910 retains theintermediate, or spacer, layer 4980 and the electronic circuit system4920 in a predetermined position against the outer surface 4111 of thehousing 4110.

The outer layer 4911 of the label 4910 includes multiple openings 4917adjacent the audio output device 4956. In this manner, sound wavesproduced by the audio output device 4956 can be transmitted to an areaoutside of the housing 4110. Similarly, the outer layer 4911 of thelabel 4910 includes openings 4918 adjacent the light emitting diodes(LEDs) 4958A and 4958B to allow the user to see the visual output. Insome embodiments, the outer layer 4911 of the label 4910 can include atransparent portion adjacent the LEDs 4958A and 4958B to allow the userto see the visual output.

The electronic circuit system 4920 includes a printed circuit board 4922upon which a microprocessor 4950, two LEDs 4958A and 4958B, two switches4972A and 4972B and various electronic components 4951, such as, forexample, resistors, capacitors and diodes, are mounted. The electroniccircuit system 4920 also includes an audio output device 4956, such as,for example, a micro-speaker, coupled to the outer surface 4111 of thehousing 4110 adjacent the printed circuit board 4922. The printedcircuit board 4922 includes a substrate 4924 upon which a series ofelectrical conductors 4934, such as for example, copper traces, areetched. The substrate 4924 can be constructed from any material havingsuitable electrical properties, mechanical properties and flexibility,such as, for example Mylar®, Kapton® or impregnated paper.

A mask layer (not shown) is disposed over the substrate 4924 toelectrically isolate selected portions of the electrical conductors 4934from adjacent components. The electrical conductors 4934 operativelycouple the above-mentioned circuit components in a predeterminedarrangement. In this manner, the electronic circuit system 4920 can beconfigured to output, via the LEDs 4958A and 4958B and/or the audiooutput device 4956, a predetermined sequence of electronic outputsduring the use of the auto-injector 4002.

Power is supplied to the electronic circuit system 4920 by two batteries4962 connected in series. The batteries can be, for example, three volt,“watch-style” lithium batteries. As shown in FIG. 9, each of thebatteries 4962 has a first surface 4964 and a second surface 4966opposite the first surface. The first surface 4964 can be, for example,an electrically negative terminal. Similarly, the second surface 4966can be an electrically positive terminal. As discussed in more detailherein, the batteries 4962 are positioned such that a first electricalcontact portion 4936 of the printed circuit board 4922 can be placed incontact with the first surface 4964 of the battery 4962 and a secondelectrical contact portion 4938 of the printed circuit board 4922 can beplaced in contact with the second surface 4966 of the battery 4962. Inthis manner, the batteries 4962 can be operatively coupled to theelectronic circuit system 4920.

As shown in FIGS. 7 and 9, a battery isolation tab 4860 is movablydisposed between the first electrical contact portion 4936 of theprinted circuit board 4922 and the first surface 4964 of one of thebatteries 4962. The battery isolation tab 4860 can be constructed fromany electrically isolative material, such as, for example, Mylar®. Asdiscussed in more detail herein, in this manner, the batteries 4962 canbe selectively placed in electronic communication with the electroniccircuit system 4920.

The intermediate, or spacer, layer 4980 is disposed between the outerlayer 4911 and the electronic circuit system 4920. The intermediatelayer 4980 includes openings (not shown) within which various componentsof the electronic circuit system, such as, for example, the batteries4962 are disposed. The intermediate layer 4980 is sized to maintain apredetermined spacing between the various components included in thelabel 4910. The intermediate layer can be constructed from any suitablematerial, such as, for example, flexible foam having an adhesivesurface, polycarbonate or the like.

FIG. 10 is a front view of the electronic circuit system 4920 showingthe arrangement of the various components (i.e., the microprocessor4950, LEDs 4958A and 4958B, switches 4972A and 4972B, audio outputdevice 4956 or the like). FIG. 11 is a schematic illustration of theelectronic circuit system 4920.

The operation of the auto-injector 4002 and the electronic circuitsystem 4920 is now discussed with reference to FIGS. 12-14. Theactuation of the electronic circuit system 4920 is performed in multiplesteps that correspond to operations that are incorporated into theprocedures for using the auto-injector 4002. In this manner, the usercan actuate various portions and/or functions of the electronic circuitsystem 4920 without completing any additional operations. Similarlystated, the electronic circuit system 4920 can produce and/or transmitelectronic outputs in response to the various stages of operation of theauto-injector 4002. Although not explicitly shown in FIGS. 5-14, in someembodiments, the electronic circuit system 4920 can include a networkinterface device, as described herein. In this manner, the electronicoutputs produced and/or transmitted by the electronic circuit system4920 can be used to track the patient compliance associated with the useof the auto-injector 4002.

Prior to use, the auto-injector 4002 is first enabled by removing theneedle guard 4810 and the safety lock 4710 (see FIGS. 12 and 13). Asillustrated by arrow AA in FIG. 12, the needle guard 4810 is removed bymoving it distally. The needle guard 4810 includes a sheath retainer4840 and a sheath 4820. The sheath 4820 is configured to receive aportion of the needle (not shown) when the needle guard 4810 is in afirst (or installed) position. The sheath retainer 4840 is coupled tothe sheath 4820 such that when the sheath retainer 4840 is moveddistally away from the base 4520 into a second (or removed) position,the sheath 4820 is removed from the needle.

The sheath retainer 4840 includes an actuator 4864 that is received byan opening 4862 in the isolation tab 4860. Accordingly, when the sheathretainer 4840 is moved distally away from the base 4520, the isolationtab 4860 is removed from the area between the first electrical contactportion 4936 of the printed circuit board 4922 and the first surface4964 of one of the batteries 4962. In this manner, the batteries 4962can be operatively coupled to the electronic circuit system 4920 whenthe needle guard 4810 is removed, thereby actuating the electroniccircuit system 4920.

When actuated, the electronic circuit system 4920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theprocessor 4950 can output an electronic signal associated with recordedspeech to the audible output device 4956. Such an electronic signal canbe, for example, associated with a .WAV file that contains a recordedinstruction instructing the user in the operation of the auto-injector4002. Such an instruction can state, for example, “remove the bluesafety tab near the base of the auto-injector.” The processor cansimultaneously output an electronic signal to the first LED 4958A,thereby causing the first LED 4958A, which is located near the safetylock 4710, to flash a particular color. In this manner, the electroniccircuit system 4920 can provide both audible and visual instructions toassist the user in the initial operation of the auto-injector 4002.

In other embodiments, the electronic circuit system 4920 can output anelectronic output associated with a description and/or status of theauto-injector 4002 and/or the medicament contained therein. For example,in some embodiments, electronic circuit system 4920 can output anaudible message indicating the type of medicament contained in theauto-injector, the expiration date of the medicament, the dosage of themedicament or the like.

As illustrated by arrow BB in FIG. 13, the safety lock 4710 is removedby moving it substantially normal to the longitudinal axis of thehousing 4110. The safety lock 4710 has a first end 4712 and a second end4714. When the safety lock 4710 is in its first (or locked) position,the second end 4714 extends around a portion of the base 4520 to spacethe base 4520 apart from the distal end portion 4114 of the housing4110. Additionally, the first end 4714 includes a locking protrusion(not shown) that obstructs portions of the system actuator (not shown)further preventing the base 4520 from being moved proximally towards thehousing 4110. Accordingly, when the safety lock 4710 is in its firstposition, the auto-injector 4002 cannot be actuated.

In some embodiments, the safety lock 4710 includes an actuator 4732 thatactuates the electronic circuit 4920 to trigger a predetermined outputor sequence of outputs when the safety lock 4710 is moved from the firstposition to a second (or unlocked) position, as shown in FIG. 13. Moreparticularly, as shown in FIGS. 10, 15 and 16, the actuator 4732includes a protrusion 4730 that is received within a first opening 4928Adefined by an actuation portion 4926 of the substrate 4924 when thesafety lock 4710 is in the first position. The boundary 4929 of thefirst opening 4928A has a discontinuous shape, such as, for example, ateardrop shape, that includes a stress concentration riser 4930. Thediscontinuity and/or the stress concentration riser 4930 of the boundary4929 can be of any suitable shape to cause the substrate 4924 to deformin a predetermined direction when the protrusion 4730 is moved relativeto the first opening 4928A.

As shown in FIGS. 15 and 16, the first opening 4928A is defined adjacentan electrical conductor 4934 that, as discussed above, electronicallycouples the components included in the electronic circuit system 4920.The electrical conductor 4934 includes a first switch 4972A, which canbe, for example a frangible portion of the electrical conductor 4934. Inuse, when the safety lock 4710 is moved from the first position to thesecond position, the actuator 4732 moves in a direction substantiallyparallel to a plane defined by a surface of the actuation portion 4926of the substrate 4924. The movement of the actuator 4732 causes theprotrusion 4730 to move within the first opening 4928A, as indicated bythe arrow DD in FIG. 16. The movement of the protrusion 4730 tears theactuation portion 4926 of the substrate 4924, thereby separating theportion of the electrical conductor 4934 including the first switch4972A. Said another way, when the safety lock 4710 is moved to thesecond position, the actuator 4732 moves irreversibly the first switch4972A from a first state (e.g., a state of electrical continuity) to asecond state (e.g., a state of electrical discontinuity).

When the actuator 4732 actuates the electronic circuit system 4920 asdescribed above, the electronic circuit system 4920 can output one ormore predetermined electronic outputs. For example, in some embodiments,the processor 4950 can output an electronic signal associated withrecorded speech to the audible output device 4956. Such an electronicsignal can be, for example, associated with a recorded message notifyingthe user of the status of the auto-injector 4002. Such a status messagecan state, for example, “The auto-injector is now enabled.” Theprocessor can also simultaneously output an electronic signal to thefirst LED 4958A, thereby causing the first LED 4958A to stop flashing,change color or the like.

In some embodiments, the electronic circuit system 4920 can beconfigured to output the status message for a predetermined time period,such as, for example, five seconds. After the predetermined time periodhas elapsed, the electronic circuit system 4920 can output an audiblemessage further instructing the user in the operation of theauto-injector 4002. Such an instruction can state, for example, “Placethe base of the auto-injector against the patient's thigh. To completethe injection, press the base firmly against the patient's thigh.” Insome embodiments, the processor can simultaneously output an electronicsignal to the second LED 4958B, thereby causing the second LED 4958B,which is located near the base 4520, to flash a particular color. Inthis manner, the electronic circuit system 4920 can provide both audibleand visual instructions to assist the user in the placement andactuation of the auto-injector 4002. In some embodiments, the electroniccircuit system 4920 can be configured to repeat the instructions after apredetermined time period has elapsed.

After the auto-injector 4002 is enabled and placed against the body ofthe patient, the auto-injector 4002 is actuated by moving the base 4520proximally towards the housing 4110, as illustrated by arrow CC in FIG.14. The base 4520 includes an actuator 4538 that actuates the electroniccircuit 4920 to trigger a predetermined output or sequence of outputswhen the base 4520 is moved from a first position to a second position,as shown in FIG. 13. The actuator 4538 includes a protrusion 4539 thatis received within a second opening 4928B (see FIG. 10) defined by thesubstrate 4924 when the base 4520 is in the first position. Theconfiguration and operation of the protrusion 4539, the second opening4928B and the second switch 4972B are similar to the configuration andoperation of the protrusion 4730, the first opening 4928A and the firstswitch 4972A, and are therefore not described in detail.

When the actuator 4538 actuates the electronic circuit system 4920, theelectronic circuit system 4920 can output one or more predeterminedelectronic outputs. For example, in some embodiments, the processor 4950can output an electronic signal associated with recorded speech to theaudible output device 4956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that theinjection is complete, instructing the user on post-injection disposaland safety procedures, instructing the user on post-injection medicaltreatment or the like. Such a status message can state, for example,“The injection is now complete. Please seek further medical attentionfrom a doctor.” The processor can also simultaneously output anelectronic signal to the first LED 4958A, thereby causing the first LED4958A to stop flashing, change color or the like, to provide a visualindication that the injection is complete.

As described above, the audio output device 4956, can include, forexample, a micro-speaker. In some embodiments, for example, the audiooutput device 4956 can include an RS-1511A micro-speaker manufactured byRegal Electronics, Inc.

Similarly, the microprocessor 4950 can be a commercially-availableprocessing device dedicated to performing one or more specific tasks.For example, in some embodiments, the microprocessor 4950 can be acommercially-available microprocessor, such as the Sonix SNC 12060 voicesynthesizer. Alternatively, the microprocessor 4950 can be anapplication-specific integrated circuit (ASIC) or a combination ofASICs, which are designed to perform one or more specific functions. Inyet other embodiments, the microprocessor 4950 can be an analog ordigital circuit, or a combination of multiple circuits.

The microprocessor 4950 can include a memory device (not shown)configured to receive and store information, such as a series ofinstructions, processor-readable code, a digitized signal, or the like.The memory device can include one or more types of memory. For example,the memory device can include a read only memory (ROM) component and arandom access memory (RAM) component. The memory device can also includeother types of memory suitable for storing data in a form retrievable bythe microprocessor 4950, for example, electronically-programmable readonly memory (EPROM), erasable electronically-programmable read onlymemory (EEPROM), or flash memory.

FIGS. 17 and 18 show an inhaler 6002 according to an embodiment of theinvention. The inhaler 6002 includes a housing 6110 and a medicamentcontainer 6262 movably disposed within the housing 6110. The medicamentcontainer 6262 includes a metering mechanism (not shown in FIGS. 17 and18) configured to discharge a predetermined volume of medicament whenthe inhaler 6002 is actuated.

The housing 6110 has a proximal end portion 6112 and a distal endportion 6114. An label 6910, which includes at least a portion of anelectronic circuit system 6920, is disposed on an outer surface 6111 ofthe housing 6110. As described above, a portion of the label 6910 caninclude a textual indicia 6916. Similar to the electronic circuitsystems shown and described above, the electronic circuit system 6920 isconfigured to output at least one electronic signal associated with theuser of the inhaler 6002. The electronic circuit system 6920 includes amicroprocessor (not shown), a microspeaker 6956 and an LED 6958. Theelectronic circuit system 6920 also includes a motion sensor 6976, thefunction of which is discussed in more detail below.

The distal end portion 6114 of the housing 6110 includes a mouthpiece6212 about which a protective cap 6710 is disposed. Prior to use, theinhaler 6002 is first enabled by removing the protective cap 6710, asshown by the arrow GG in FIG. 18. The protective cap 6710 includes anactuator 6732 that actuates the electronic circuit system 6920 totrigger a predetermined output or sequence of outputs when theprotective cap 6710 is removed. In some embodiments, the actuator 6732can include a protrusion that is received by an actuation portion of theelectronic circuit system 6920, in a similar manner as described above.In other embodiments, the actuator 6732 can be configured to engage amicroswitch that can be repeatedly moved between a first state and asecond state.

When actuated, the electronic circuit system 6920 can output one or morepredetermined electronic outputs. For example, in some embodiments, theelectronic circuit system 6920 can output an audible message via themicrospeaker 6956 instructing the user to “vigorously shake the inhalerfor five seconds.” The processor can simultaneously enable the motionsensor 6976.

Upon receiving a predetermined input from the motion sensor 6976, whichcan be any sensor suitable for detecting the rapid motion of the inhaler6002, the processor can then send an electronic signal to produce asecond audible message. Such a message can state, for example, “theinhaler is now sufficiently shaken and is ready for use.” In someembodiments, the electronic circuit system 6920 can also output aninstruction associated with the correct placement of the inhaler 6002.For example, the electronic circuit system 6920 can output an audiblemessage stating “please place the mouthpiece in your mouth and firmlypress down on the medicament container.” The electronic circuit system6920 can also simultaneously output a signal to the LED 6958 to providea visual indication of where the mouthpiece 6212 is located.

After the inhaler 6002 is enabled and placed within the mouth of thepatient, the inhaler 6002 is actuated by moving the medicament container6262 distally within housing 6110, as illustrated by arrow HH in FIG.18. In some embodiments, the medicament container 6262 can include anactuator (not shown) that actuates the electronic circuit 6920, in amanner similar to those described above, to trigger a predeterminedoutput or sequence of outputs. For example, in some embodiments, theprocessor can output an electronic signal associated with recordedspeech to the microspeaker 6956. Such an electronic signal can be, forexample, associated with a recorded message notifying the user that themedicament delivery is complete, instructing the user on post-inhalationprocedures, instructing the user on post-inhalation medical treatment orthe like. Such a status message can state, for example, “The delivery ofmedication is now complete.”

As described above, although not explicitly shown in FIGS. 5-14, in someembodiments, an electronic circuit system of a medicament deliverydevice can include a network interface device. Similarly stated, in someembodiments, the auto-injector 4002 can be configured to send electronicsignals to and/or receive electronic signals from a communicationsnetwork and/or a remote device. The remote device can be, for example, acompliance monitoring device, a computer, a cell phone, a personaldigital assistant (PDA) or the like. In this manner, the auto-injector4002 can facilitate electronic and/or automatic compliance monitoringas1ociated with its use.

In some embodiments, for example, a medicament delivery device caninclude a network interface device configured to send and/or receiveelectrical signals via a wireless network. For example, FIG. 19 is aschematic illustration of a medicament delivery device 7002 according anembodiment of the invention that includes a wireless communicationssystem 7985. The wireless communications system 7985 is configured tosend and/or receive one or more electronic signals S1 to a variety ofcommunications devices 7990 via a wireless communications network N_(W).The wireless communication network N_(W) includes a wireless accesspoint (WAP) 7988 configured to operatively connect the communicationsdevices 7990 and the wireless communications system 7985 on themedicament delivery device 7002 to form the wireless communicationsnetwork N_(W). As described herein, the communications devices 7990 caninclude, for example, a laptop computer, a personal digital assistant, acompliance monitoring device, a stand-alone processor, a workstationand/or the like. Moreover, as shown in FIG. 19, the communicationsdevices 7990 can be configured to communicate electronically to aninternet server 7991 by sending electronic signals to and/or receivingelectronic signals from the internet server. In this manner, thewireless communications system 7985 can transmit information associatedwith the medicament delivery device 7002 to and/or receive informationassociated with the medicament delivery device 7002 from any number ofthird party devices 7992 located anywhere in the world.

In use, the wireless communications system 7985 can be used to sendand/or receive information associated with the medicament deliverydevice 7002. Such information can include, for example, informationassociated with the frequency with which medicament delivery device 7002is used (e.g., a compliance log), the functionality of the medicamentdelivery device 7002 after use (e.g., the number of doses remaining),the date and/or time of use, a parameter measuring the success of thelatest use of the medicament delivery device 7002, an expiration date ofthe medicament delivery device 7002 and/or the medicament containedtherein, a status of the medicament delivery device 7002 and/or themedicament contained therein, instructions for using the medicamentdelivery device 7002, the need for additional medical devices, the needfor additional drug dosages, and/or any other information that may beuseful to users and/or medical professionals associated with themedicament delivery device 7002. For example, in some embodiments, thewireless communications system 7985 can send one or more signals S1including information related to a user's compliance to the user's homecomputer and/or a compliance monitoring device. In this manner, the usercan use their home computer to track their compliance with a prescribedmedication regimen or other usage of the medicament delivery device7002. In other embodiments, the wireless communications system 7985 cansend one or more signals S1 including information related to a user'scompliance to a third party. Such third parties can include, forexample, a health care provider, an emergency contact, a manufacturer ofthe medicament delivery device 7002, a pharmaceutical benefits manager(PBM), a specialty pharmacy, a payor (e.g., an insurance company), aclinical trial administrator, an on-line support group or forum, and/ora pharmaceutical company. For example, in some embodiments, the wirelesscommunications system 7985 can send one or more signals S1 includinginformation related to a user's compliance to the user's health careprovider. In this manner, the health care provider can monitor theuser's compliance with the prescribed medication regimen.

The wireless communications system 7985 can include any hardware,software and/or firmware suitable for wireless communication. Forexample, in some embodiments, the wireless communications system 7985can include a microprocessor, a transmitter, a receiver, a transceiver,a microchip, a radio chipset, a wireless interface card (WIC), a hostcontroller interface (HCI), a universal asynchronousreceiver/transmitter (UART), a power source (e.g., a battery), one ormore sensors, a transponder, an antenna, a crystal, a circuit board, aliquid crystal display (LCD), a Small Computer System Interface (SCSIand ports), a FireWire (or other IEEE 1394 interfaces), a data uplink, adata downlink, a point-to-point link, a fiber optic link, a storagedevice (e.g., hard drive, flash drive or the like), a personal computercards, a docking stations, a parallel and/or bit-serial connections, aUniversal Serial Bus (USB) port or other serial ports, a light emittingdiode (LEDs), a speaker, an amplifier, radiofrequency identification(RFID) devices and/or other common electronic components used forwireless communication. The electronic components can be operativelycoupled to form the wireless communications system 7985 by any suitablecircuitry. In some embodiments, the wireless communications system 7985can include the components used for wireless communication on a singlechip, such as, for example, the Bluetooth™ radio chip LMX9830manufactured by National Semiconductor.

As described above, the wireless access point WAP is configured toestablish the wireless network N_(W) and to transmit electronic signalsbetween the medicament delivery device 7002 (which can be referred to asa wireless client device), wireless communications devices 7990 (whichcan be referred to as other wireless client devices) and/or other thirdparty devices 7992. In some embodiments, the wireless communicationsdevices 7990 and/or other third party devices 7992 can include, forexample, laptops (computers), personal digital assistants (PDAs),wireless IP phones, servers, routers, and other wireless enabled networkdevices. Although the wireless access point WAP is shown and describedas being distinct from the wireless communications system 7985, in someembodiments, the wireless communications system 7985 can include thefunctionality of a wireless access point. In this manner, the medicamentdelivery device 7002 can be utilized as a wireless access point. In yetother embodiments, the wireless communications system 7985 can sendand/or receive electronic signal S1 without the use of a wireless accesspoint. In such embodiments, which can be referred to as peer-to-peernetworks or ad-hoc networks, the wireless communications system 7985 cancommunicate directly with the wireless communications devices 7990and/or other third party devices 7992.

The wireless communication system 7985 can employ any suitable protocolor protocols for sending and/or receiving the electronic signals S. Suchprotocols can include, for example, Wi-Fi, Bluetooth™, Zigbee, Wi-Max,802.XX, HomeRF, any protocols associated with Radio FrequencyIdentification (RFID) transmission and/or a combination thereof. In someembodiments, the wireless communications system 7985 can employ aprotocol having heightened security, such as for example, varying levelsof encryption. In this manner any information associated with themedical records of a user can be protected against unauthorized access.

In addition to encryption, in some embodiments, the informationtransmitted and/or received by the wireless communication system 7985can be in a format configured to prevent the identification of the user.For example, in some embodiments, the information transmitted and/orreceived by the wireless communication system 7985 can be associatedwith a unique identification number known only by certain parties, suchas, for example, the end user and the end user's physician.

The wireless communications network N_(W) can have any suitable range.For example, in some embodiments, the wireless communications networkN_(W) can be a wireless local area network (WLAN). A WLAN can besuitable in certain conditions in which the communications devices 7990are confined to a limited geographical area, such as, for example,within a hospital, a nursing home or a triage unit. In otherembodiments, the wireless communications network N_(W) can be a wirelessmetropolitan area network (WMAN). A WMAN can be suitable in certainconditions in which the communications devices 7990 are used within apredefined area that cannot easily be covered by a WLAN, such as, forexample, within a city. In yet other embodiments, the wirelesscommunications network N_(W) can be a wireless wide area network (WWAN).

Although the arrangement shown in FIG. 19 shows the wirelesscommunication system 7985 sending information to and/or receivinginformation from the third party devices 7992 via the wireless accesspoint 7988 and the wireless communications devices 7990, in otherembodiments, the wireless communication system 7985 can transmitinformation to and/or receive information from the third party devices7992 directly. For example, in some embodiments, third party devices7992 can be included within the wireless communications network N_(W),which can be, for example, a wireless wide area network (WWAN).

The medicament delivery device 7002 can be any device suitable fordelivering one or more doses of a medicament into a patient's body. Asdescribed herein, such devices can include, for example, auto-injectors,pen injectors, inhalers, transdermal patches, pre-filled syringes (PFS),syringes, catheters, stents, implantable vehicles, topical vehicles,pill dispensers or the like. In some embodiments, for example, themedicament delivery device 7002 can be a single-dose device typicallyused in emergency situations. For example, in some embodiments, themedicament delivery device 7002 can be a single-use medical injector,similar to auto-injector 4002 shown and described above with referenceto FIGS. 5-16. In such embodiments, the wireless communications system7985 can be configured to send automatically data to a workstationand/or a compliance monitoring device during the various stages ofoperation of the medicament delivery device 7002. In this manner, thedetails of each stage of operation of the medicament delivery device7002 can be electronically and/or automatically recorded to trackpatient compliance. Such details can include, for example, a time stampassociate with the removal of a safety mechanism (i.e., the “arming” ofthe medicament delivery device), a time stamp associated with theactuation of the medicament delivery device, an indicator associatedwith the validity of the medicament delivery event and/or the like.

In other embodiments, the medicament delivery device 7002 can be achronic-care medicament delivery device containing multiple doses ofmedicament configured to be delivered on a regular schedule. In someembodiments, for example, the medicament delivery device 7002 can be achronic-care pen injector used for injectable pharmaceuticals thatrequire daily, weekly and/or monthly injections, such as, for example,insulin or human growth hormone (HgH). In such embodiments, the wirelesscommunication system 7985 can track the usage of the pen injector andtransmit the use information to the patient's physician, specialtypharmacy, payor (e.g., an insurance company), PBM, clinical trialadministrator or other provider. In this manner, for example, thepatient's physician can ensure that the therapy regime is effective.

In yet other embodiments, the medicament delivery device 7002 can be asingle-use and/or disposable chronic-care medicament delivery device. Asdescribed in more detail herein, in such embodiments the medicamentdelivery device 7002 can be included within a kit containing the desirednumber of doses of medicament.

As described above, in some embodiments, a medicament delivery devicecan be configured to produce and/or output an electrical signal when themedicament delivery device is actuated. In this manner, patientcompliance data, such as, for example, the frequency of use, the dateand time of use and/or a parameter measuring the success and/or validityof the use of the medicament delivery device can be monitored based onthe actuation of the medicament delivery device, rather than on theremoval of a safety interlock from the medicament delivery device. Forexample, FIGS. 20-22 are schematic illustrations of a medical system3000 according to an embodiment of the invention, in a firstconfiguration, a second configuration and a third configuration,respectively. The medical system 3000 includes a medicament deliverydevice 3002 and a container 3010. As shown in FIG. 20, the container3010 is configured to receive at least a portion of the medicamentdelivery device 3002. For example, in some embodiments, the container3010 can include a recessed portion, a retainer, and/or any othersuitable structure that matingly receives at least a portion of themedicament delivery device 3002.

The container 3010 includes an electronic circuit system 3020 configuredto output at least electronic signals S2 and S4, as described in moredetail herein. The electronic circuit system 3020 can include anysuitable electronic components operatively coupled to produce and/oroutput the electronic signal S2 and S4, and/or to perform the functionsdescribed herein. The electronic circuit system 3020 is operativelycoupled to the communications network N_(W), which includes at least apersonal computer (PC) 3990 or other processor, and an internet server3991. In some embodiments, for example, the electronic circuit system3020 can include a wireless communications device, similar to thewireless communications system 7985 shown and described above withreference to FIG. 19, to wirelessly connect the electronic circuitsystem 3020 to the PC 3990 and/or the communications network N_(W). Inother embodiments, the electronic circuit system 3020 can be operativelycoupled to the PC 3990 and/or the communications network N_(W) via awired connection. In this manner, as described in more detail herein,the electronic circuit system 3020 of the container 3010 can transmitinformation associated with the medical system 3000 to and/or receiveinformation associated with the medical system 3000 from any number ofremotely located third party devices (not shown in FIGS. 20-22).

The medicament delivery device 3002 can be any device for delivering amedicament into a body, such as, for example, a medical injector (whichcan include an auto-injector, a pen injector, a multiple-use injector, asyringe or the like), an inhaler or the like. The medicament deliverydevice 3002 includes an actuator 3970 and an electronic circuit system3920. The actuator 3970 is movable between a first position (FIGS. 20and 21) and a second position (FIG. 22). When the actuator 3970 is movedfrom the first position to the second position, the actuator 3970initiates the delivery of the medicament into the body. In someembodiments, the actuator 3970 can be configured to release a spring, anenergy storage member, or the like, to initiate medicament delivery whenthe actuator 3970 is moved from the first position to the secondposition. For example, in some embodiments, the actuator can be similarto the base 4520 shown and described above with reference to FIGS. 5-16.

The electronic circuit system 3920 of the medicament delivery device3002 is configured to output at least an electronic signal S3 (see FIG.22) when the actuator 3970 is moved from the first position to thesecond position. The electronic circuit system 3920 of the medicamentdelivery device 3002 can include any suitable electronic componentsoperatively coupled to produce and/or output the electronic signal S3and/or to perform the functions described herein. In some embodiments,for example, the electronic circuit system 3920 of the medicamentdelivery device 3002 can be similar to the electronic circuit system4920 shown and described above with reference to FIGS. 5-16.

The medical system 3000 can be used to manage the patient's medicationregimen and/or track the patient's compliance in following theprescribed medication regimen. When the medical system 3000 is in thefirst configuration (i.e., the “storage configuration”), as shown inFIG. 20, at least a portion of the medicament delivery device 3002 isdisposed within the container 3010, and the electronic circuit system3020 of the container 3010 is operatively coupled to the communicationsnetwork N_(W), and/or the personal computer (PC) 3990. In someembodiments, when the medical system 3000 is in the first configuration,the electronic circuit system 3020 can optionally output one or moreelectronic signals (not shown in FIG. 20) associated with the medicationregimen and/or the medicament delivery device 3002. Such electronicsignals can include, for example, a visual and/or an audible outputreminding the patient of the date and time of the next dosage,indicating the expiration date of the medicament delivery device,providing instructions in the use of the medicament delivery device,providing instructions for monitoring compliance, or the like.

To move the medical system 3000 from the first configuration to thesecond configuration (i.e., a “pre-delivery” configuration), themedicament delivery device 3002 is removed from the container 3010, asshown by the arrow JJ in FIG. 21. When the medicament delivery device3002 is removed from the container 3010, the electronic circuit system3020 of the container 3010 produces the first electronic signal S2. Thefirst electronic signal S2 can be associated with the prescribedmedication regimen (including, for example, compliance data), anidentification of the medicament delivery device 3002, a status of themedicament delivery device 3002, a use instruction associated with themedicament delivery device 3002, a status of the container 3010(including, for example, an indication of whether the electronic circuitsystem 3020 of the container 3010 is connected to the network N_(W), theremaining battery life of a battery powering the electronic circuitsystem 3020, or the like), a use instruction associated with thecontainer 3010 and/or the like. In some embodiments, for example, thefirst electronic signal S2 can include a visual output, an audibleoutput and/or a haptic output that instructs and/or provides cues to auser in the use of the container 3010 to track the patient's compliance.In other embodiments, the first electronic signal S2 can include acommunications signal that can be transmitted via the PC 3990 and theinternet server 3991 to a remotely located third party device (not shownin FIGS. 20-22).

To move the medical system 3000 from the second configuration to thethird configuration (i.e., a “post-delivery” configuration), themedicament delivery device 3002 is actuated by moving the actuator 3970from the first position (FIG. 21) to the second position (FIG. 22), asshown by the arrow KK in FIG. 22. When the actuator 3970 is moved fromthe first position to the second position, actuation of the medicamentdelivery device is initiated. Said another way, the actuator 3970 isconfigured to initiate delivery of the medicament when the actuator 3970is moved from the first position to the second position. As describedabove, the actuator 3970 can be configured to release a spring, anenergy storage member, or the like, to initiate medicament delivery whenthe actuator 3970 is moved from the first position to the secondposition.

When the actuator 3970 is moved from the first position to the secondposition, the electronic circuit system 3920 of the medicament deliverydevice 3002 outputs the second electronic signal S3. Said another way,when actuator 3970 is moved from the first position to the secondposition, the actuator 3970 actuates the electronic circuit system 3920of the medicament delivery device 3002 such that the electronic circuitsystem 3920 produces and/or outputs the second electronic signal S3. Insome embodiments, the movement of the actuator 3970 produces an inputthat is received by the electronic circuit system 3920, therebytriggering the electronic circuit system 3920 to produce and/or out thesecond electronic signal S3. Said another way, in some embodiments, themovement of the actuator 3970 changes the state of a switch (not shownin FIGS. 20-22) within the electronic circuit system 3920, therebytriggering the electronic circuit system 3920 to produce and/or outputthe second electronic signal S3. Such a switch can be either reversibleor irreversible, as described above. For example, in some embodiments,the movement of the actuator 3970 can separate, tear, deform and/orsever an electrical conductor (not shown in FIGS. 20-22) within theelectronic circuit system 3920. For example, in some embodiments, theactuator 3970 can include a protrusion (not shown in FIGS. 20-22)configured to be received within and sever a portion of the electroniccircuit system 3920, similar to the protrusion 4730 shown and describedabove with reference to FIGS. 14-16. In other embodiments, the movementof the actuator 3970 can electronically couple and/or decouple a powersource (not shown in FIGS. 20-22) to a portion of the electronic circuitsystem 3920. For example, in some embodiments, the actuator 3970 caninclude a battery isolation tab (not shown in FIGS. 20-22) configured toisolate a battery from a portion of the electronic circuit system 3920,similar to the battery isolation tab 4860 shown and described above withreference to FIGS. 7, 9 and 12.

The second electronic signal S3 is received by the electronic circuitsystem 3020 of the container 3010, which then produces the thirdelectronic signal S4. The third electronic signal S4 is associated withthe second electronic signal S3. In this manner, the electronic circuitsystem 3020 of the container 3010 and the electronic circuit system 3920of the medicament delivery device 3002 can cooperatively monitor thepatient's compliance in using the medicament delivery device 3002. Byutilizing two electronic circuit systems, the electronic circuit system3920 and the electronic circuit system 3020 can be cooperativelydesigned to provide the desired functionality. For example, in someembodiments, the container 3010 can be a reusable compliance trackingdevice and the medicament delivery device 3002 can be a single-use,disposable device. In such an arrangement, the electronic circuit system3020 of the container 3010 can include complicated circuit elements,circuit elements having a higher cost, and/or circuit elements havinghigher power consumption (e.g., speakers, long-range wirelesscommunications systems and the like). Conversely, the electronic circuitsystem 3920 of the medicament delivery device 3002 can include fewercircuit elements, circuit elements having a lower cost, and/or circuitelements having lower power consumption. In some embodiments, forexample, the electronic circuit system 3920 of the medicament deliverydevice 3002 can include a transceiver (not shown in FIGS. 20-22) thatconsumes less than approximately 100 mA (at a supply voltage ofapproximately 1.8 volts) when outputting the second electronic signalS3. In other embodiments, the electronic circuit system 3920 of themedicament delivery device 3002 can include a transceiver (not shown inFIGS. 20-22) that consumes less than approximately 20 mA (at a supplyvoltage of approximately 1.8 volts) when outputting the secondelectronic signal S3. Such an arrangement can facilitate the use of theelectronic circuit system 3920 on a single-use, disposable medicamentdelivery device.

The second electronic signal S3 can be any suitable communicationssignal (e.g., a radio frequency signal) that can be received by theelectronic circuit system 3020 of the container 3010. For example, insome embodiments, the second electronic signal S3 can be a short-rangeradio frequency signal having a range of approximately 100 meters orless. In some embodiments, the second electronic signal S3 can be aBluetooth™-compatible electronic signal, including either a class 1,class 2 or class 3 signal. Said another way, in some embodiments, theelectronic circuit system 3920 of the medicament delivery device 3002and the electronic circuit system 3020 of the container 3010 can beBluetooth™-enabled circuits. In this manner, the medicament deliverydevice 3002 can electronically communicate with the container 3010 usinglow-cost circuit elements and/or using circuit elements having minimalpower consumption.

The third electronic signal S4 can be any suitable electronic signalthat can be produced and/or output by the electronic circuit system 3020of the container 3010. For example, in some embodiments, the thirdelectronic signal S4 can be output to an audio output device and/or avideo output device (not shown in FIGS. 20-22) within the electroniccircuit system 3020. In this manner, the electronic circuit system 3020of the container 3010 can produce an audible and/or a visual outputassociated with the actuation of the medicament delivery device 3002.For example, in some embodiments, the third electronic signal S4 can beoutput to a speaker of the types shown and described above, therebyproviding the user with a message associated with the use of and/or thecompliance with the medicament delivery device 3002. In someembodiments, the third electronic signal S4 can be associated with amessage instructing the user on post-injection disposal, safetyprocedures, post-injection medical treatment or the like. Such a messagecan state, for example, “THE DOSAGE OF XXX HAS BEEN SUCCESSFULLYADMINISTERED. PLEASE SEEK FURTHER MEDICAL ATTENTION FROM A DOCTOR IF THEFOLLOWING SYMPTOMS OCCUR . . . ” In other embodiments, the thirdelectronic signal S4 can be associated with a message related toprocedures for tracking compliance with the medication regimen. Such amessage can state, for example, “THE SUCCESSFUL DOSAGE OF XXX HAS BEENRECORDED TO YOUR ELECTRONIC COMPLIANCE LOG. NO FURTHER ACTION ISREQUIRED.” In other embodiments, such a message can state, “PLEASEENSURE THAT YOU RECORD THE CORRECT DOSAGE IN YOUR ELECTRONIC LOGBOOK.”In yet other embodiments, such a message can state, “PLEASE DO NOT EATOR DRINK UNTIL XX P.M.” In yet other embodiments, such a message canstate, “THE COMPLIANCE MONITOR IS CURRENTLY DISCONNECTED FROM THENETWORK. PLEASE ENSURE THAT THE COMPLIANCE MONITOR IS CONNECTED TO YOURHOME COMPUTER.”

In some embodiments, the third electronic signal S4 can be acommunications signal (e.g., a radio frequency signal) that can betransmitted from the electronic circuit system 3020 of the container3010 to the PC 3990 and/or the communications network N_(W). Suchtransmission can occur using any suitable method and/or protocol. Thethird electronic signal S4 can be transmitted, for example, in the formof an e-mail, a phone call, a data stream or the like.

In some embodiments, for example, the third electronic signal S4 can beassociated with the patient's compliance in using the medicamentdelivery device 3002. For example, in some embodiments, the thirdelectronic signal S4 can be sent via the communications network N_(W) tothe patient's pharmacy to automatically order additional pre-filledmedicament delivery devices and/or replacement cartridges for themedicament delivery device. In other embodiments, the third electronicsignal S4 can be sent via the communications network N_(W) to a healthcare provider, thereby allowing the health care provider to remotelymonitor the patient's medication regimen. In yet other embodiments, thethird electronic signal S4 can be sent via the communications networkN_(W) to a clinical trial administrator, thereby allowing the clinicaltrial administrator to ensure that the clinical trial protocols arebeing properly followed.

FIG. 23 is a flow chart of a method 10 according to an embodiment of theinvention. The method includes moving an actuator on a medicamentdelivery device to initiate delivery of a medicament into a body, 12.The actuator can be any suitable actuator configured to initiate thedelivery of medicament into the body, as described above. For example,in some embodiments, the actuator can be configured to release a spring,an energy storage member, or the like, to initiate medicament deliverywhen the actuator is moved. In some embodiments, the method canoptionally include moving one or more safety locks before the actuatoris moved. Such safety locks can be similar to the safety lock 4710 shownand described above with reference to FIGS. 5-16, and can be configuredto prevent the actuator from being moved.

A first electronic signal is then output from a first electronic systemin response to the movement of the actuator, 14. The first electronicsignal is a short-range radio frequency signal having a range ofapproximately 100 meters or less. In some embodiments, for example, thefirst electronic signal can be a Bluetooth™-compatible electronicsignal, including either a class 1, a class 2 or a class 3 signal. Inother embodiments, the first electronic signal can be a short-rangesignal produced by a radio frequency identification (“RFID”) tag withinthe first electronic circuit system. In this manner, the firstelectronic circuit system can produce and/output the first electronicsignal using electronic devices having a low power consumption, asdescribed above. As described in more detail herein, in someembodiments, the first electronic circuit system can be devoid of abattery.

The first electronic circuit system can be any suitable electroniccircuit system of the types shown and described herein. For example, insome embodiments, at least a portion of the first electronic circuitsystem can be disposed on the housing of the medicament delivery device.In other embodiments, at least a portion of the first electronic circuitsystem can be disposed on a portion of the medicament delivery devicethat is removably coupled to the housing of the medicament deliverydevice (e.g., a removable protective sheath, a removable safety lock orthe like). In some embodiments, for example, a medicament deliverydevice can include a protective sheath that includes a first portion ofthe first electronic circuit system, and a housing that includes asecond portion of the first electronic circuit system. In suchembodiments, the first portion of the first electronic circuit systemcan include a processor configured to control the second portion of thefirst electronic circuit system and/or a battery configured to providepower to the second portion of the first electronic circuit system.Similarly, the second portion of the first electronic circuit system caninclude a processor configured to control the first portion of the firstelectronic circuit system and/or a battery configured to provide powerto the first portion of the first electronic circuit system.

A second electronic signal is then output from a second electroniccircuit system, 16. The second electronic signal is associated with thefirst electronic signal. Similarly stated, the second electronic circuitsystem outputs the second electronic signal in response to the firstelectronic signal. In some embodiments, for example, the secondelectronic signal can include information associated with and/orincluded within the first electronic signal, such as, for example, thedate and time when the first electronic signal was received by thesecond electronic circuit system. In other embodiments, the secondelectronic signal can include information identifying the contents ofthe medicament delivery device (e.g., the amount and type of medicamentcontained therein), an expiration date of the medicament deliverydevice, or the like.

As described above, the second electronic signal can be any suitableelectronic signal that can be produced and/or output by the secondelectronic circuit system. For example, in some embodiments, the secondelectronic signal can be output to an audio output device and/or a videooutput device. In other embodiments, the second electronic signal can bea communications signal (e.g., a radio frequency signal) that can betransmitted from the second electronic circuit system to the user'scomputer, a communications network N_(W), and/or a remotely locateddevice.

FIGS. 24-27 show a medical system 12000 according to an embodiment ofthe invention, in a first configuration, a second configuration, a thirdconfiguration, and a fourth configuration, respectively. The medicalsystem 12000 includes a medicament delivery device 12002 (see e.g., FIG.25) and a compliance monitoring device 12510. As shown in FIG. 25, thecompliance monitoring device 12510 includes a hinged lid 12518, anelectronic circuit system 12530, a first switch 12536 and a secondswitch 12537. Additionally, the compliance monitoring device 12510defines an internal region 12512 within which the medicament deliverydevice 12002 can be contained.

The electronic circuit system 12530 of the compliance monitoring device12510 is configured to produce and/or output one or more electronicoutputs and/or electronic signals of the type described above. Asdescribed in more detail below, the electronic circuit system 12530includes a speaker 12544 and an LCD screen 12542. Moreover, similar tothe container 3010 shown and described above with reference to FIGS.20-22, the electronic circuit system 12530 of the compliance monitoringdevice 12510 is operatively coupled to a personal computer (PC) 12990.In this manner, as described in more detail herein, the electroniccircuit system 12530 of the compliance monitoring device 12510 cantransmit information associated with the medical system 12000 to and/orreceive information associated with the medical system 12000 from anynumber of remotely located third party devices (not shown in FIGS.24-27) via the PC 12990.

The hinged lid 12518 has a first position (see FIG. 24) and a secondposition (see FIGS. 25-27). When the hinged lid 12518 is in the firstposition, the hinged lid 12518 covers the internal region 12512 of thecompliance monitoring device 12510. Conversely, when the hinged lid12518 is in the second position, at least a portion of the internalregion 12512 of the compliance monitoring device 12510 is exposed. Saidanother way, when the hinged lid 12518 is in the second position, themedicament delivery device 12002 can be removed from the internal region12512 of the compliance monitoring device 12510.

The electronic circuit system 12530 of the compliance monitoring device12510 is operatively coupled to the first switch 12536 and the secondswitch 12537. The first switch 12536 is configured to move between afirst state (e.g., closed) and a second state (e.g., opened) when thehinged lid 12518 moves between its first position and its secondposition, as indicated by arrow LL in FIG. 25. The electronic circuitsystem 12530 is configured to produce and/or output a first output OP1via the speaker 12544 when the first switch 12536 is moved from itsfirst state to its second state. The first output OP1 can be a recordedspeech output associated with an identification of the medicamentdelivery device 12002, an identification of patient symptoms (e.g.,instructions for assessing the physical condition of the patient), aninstruction for using the medicament delivery device 12002, aninstruction for using the compliance monitoring device 12510, a messageguiding the patient in procedures for adhering to the prescribedmedication regimen, a status of the compliance monitoring device 12510and/or a status of the patient's compliance with the prescribedmedication regimen. For example, in some embodiments the first outputOP1 can state “YOU HAVE ACTIVATED THE ALLERGIC REACTION RESPONSE KIT.THIS KIT INCLUDES AN AUTO-INJECTOR CONTAINING EPINEPHRINE. BEFORE USINGTHIS AUTO-INJECTOR, PLEASE ENSURE THAT THE PATIENT IS EXHIBITING THEFOLLOWING SYMPTOMS . . . . ” In other embodiments, the first output OP1can state “YOUR NEXT DOSAGE IS NOT DUE UNTIL XX P.M. PLEASE DO NOTADMINISTER THE DOSE AT THIS TIME.” In yet other embodiments, the firstoutput OP1 can state “BECAUSE THE MEDICAMENT HAS BEEN REFRIGERATED FORSTORAGE, THE MEDICAMENT IS CURRENTLY TOO COLD. THE CURRENT TEMPERATUREOF THE MEDICAMENT IS XX DEGREES, PLEASE LEAVE THE MEDICAMENT AT ROOMTEMPERATURE FOR XX MINUTES BEFORE ADMINISTERING THE DOSE.” In yet otherembodiments, the first output OP1 can state “THIS IS THE LAST DOSE INTHE CURRENT PRESCRIPTION. AFTER ADMINISTERING THIS DOSE, PLEASE CONTACTYOUR HEALTH CARE PROVIDER FOR FURTHER ADVICE.” Although described as anaudible output, in other embodiments, the first output OP1 can be anytype of electronic output as described herein.

The second switch 12537 is configured to move between a first state(e.g., closed) and a second state (e.g., opened) when the medicamentdelivery device 12002 is removed from the internal region 12512 of thecompliance monitoring device 12510, as indicated by the arrow MM in FIG.26. The electronic circuit system 12530 of the compliance monitoringdevice 12510 is configured to output a second output OP2 via the speaker12544 and/or the LCD screen 12542 when the second switch 12537 is movedfrom its first state to its second state. The second output OP2 can be,for example, a recorded speech output and/or a video output associatedwith an identification of the medicament delivery device 12002, anidentification of patient symptoms (e.g., instructions for assessing thephysical condition of the patient), an instruction for using themedicament delivery device 12002, an instruction for using thecompliance monitoring device 12510, a status of the compliancemonitoring device 12510 and/or a status of the patient's compliance withthe prescribed medication regimen. For example, in some embodiments thesecond output OP2 can be an audio-visual output via both the speaker12544 and the LCD screen 12542 providing step-by-step instructions forusing the medicament delivery device 12002 and/or the compliancemonitoring device 12510.

The medicament delivery device 12002 can be any device for delivering amedicament into a body, of the types shown and described herein. Themedicament delivery device 12002 includes an actuator 12970 and anelectronic circuit system 12920. The actuator 12970 is movable between afirst position (FIG. 26) and a second position (FIG. 27). When theactuator 12970 is moved from the first position to the second position,the actuator 12970 initiates the delivery of the medicament into thebody. In some embodiments, the actuator 12970 can be similar to the base4520 shown and described above with reference to FIGS. 5-16.

The electronic circuit system 12920 of the medicament delivery device12002 is configured to output at least an electronic signal S5 (see FIG.27) when the actuator 12970 is moved from the first position to thesecond position. The electronic circuit system 12920 of the medicamentdelivery device 12002 can include any suitable electronic componentsoperatively coupled to produce and/or output the electronic signal S5and/or to perform the functions described herein. In some embodiments,for example, the electronic circuit system 12920 of the medicamentdelivery device 3002 can be similar to the electronic circuit system4920 shown and described above with reference to FIGS. 5-16.

The medical system 12000 can be used to manage the patient's medicationregimen and/or track the patient's compliance in following theprescribed medication regimen in a similar manner as described abovewith reference to the medical system 3000. To move the medical system12000 from a storage configuration (FIG. 24) to a pre-deliveryconfiguration (FIG. 26), the hinged lid 12518 is moved, as shown by thearrow LL in FIG. 25, and the medicament delivery device 12002 is removedfrom the compliance monitoring device 12510, as shown by the arrow MM inFIG. 26. As described above, the movement of the hinged lid 12518produces an input to the electronic circuit system 12530 via the firstswitch 12536. The input from the first switch 12536 triggers theelectronic circuit system 12530 to produce and/or output the firstoutput OP1, as discussed above. Similarly, when the medicament deliverydevice 12002 is removed from the internal region 12512 of the compliancemonitoring device 12510, the second switch 12537 produces an input tothe electronic circuit system 12530. The input from the second switch12537 triggers the electronic circuit system 12530 to produce and/oroutput the second output OP2, as discussed above.

To administer the medication (i.e., to move the medical system 12000 toa post-delivery configuration, as shown in FIG. 27), the medicamentdelivery device 12002 is first positioned adjacent a portion of a body Bof a patient. Although the portion of the body B is shown as being asurface, such as, for example, the skin, in other embodiments, theportion of the body B can be any suitable location for delivering themedicament (e.g., the mouth, the nasal passages, or the like). Themedicament delivery device 12002 is then actuated by moving the actuator12970 from the first position (FIG. 26) to the second position (FIG.27), as shown by the arrow NN in FIG. 27.

When the actuator 12970 is moved from the first position to the secondposition, the electronic circuit system 12920 of the medicament deliverydevice 12002 outputs the electronic signal S5. Said another way, whenactuator 12970 is moved from the first position to the second position,the actuator 12970 actuates the electronic circuit system 12920 of themedicament delivery device 12002 such that the electronic circuit system12920 produces and/or outputs the electronic signal S5. The actuator12970 can actuate the electronic circuit system 12920 in any manner asdescribed herein. The electronic signal S5 can be any suitablecommunications signal, as described herein.

In a similar manner as described above with reference to the medicalsystem 3000, the electronic signal S5 is received by the electroniccircuit system 12530 of the compliance monitoring device 12510, whichthen produces the third electronic output OP3. The third electronicoutput OP3 is associated with the electronic signal S5. For example, thethird electronic output OP3 can include a date and time stampdocumenting when the electronic signal S5 was received. In someembodiments, the third electronic output OP3 can include informationincluded within the electronic signal S5, such as a uniqueidentification of the medicament delivery device 12002. In this manner,the electronic circuit system 12530 of the compliance monitoring device12510 and the electronic circuit system 12920 of the medicament deliverydevice 12002 can cooperatively monitor the patient's compliance in usingthe medicament delivery device 12002. As described above, in someembodiments, the third electronic output OP3 includes a communicationssignal (e.g., a radio frequency signal) that can be transmitted from theelectronic circuit system 12530 of the of the compliance monitoringdevice 12510 to the PC 12990.

Although the electronic circuit system 12530 of the compliancemonitoring device 12510 is shown and described as receiving theelectronic signal S5 from medicament delivery device 12002 in real-timewhen the medicament delivery device 12002 is actuated, in otherembodiments, the electronic signal S5 can be received by the electroniccircuit system 12530 of the compliance monitoring device 12510 at anytime after the medicament delivery device 12002 has been actuated. Forexample, in some embodiments, the electronic signal S5 can be ashort-range radio frequency signal having a range of approximately 100meters or less. Accordingly, in certain instances, the medicamentdelivery device 12002 may be actuated when the medicament deliverydevice 12002 is out of transmission range for transmitting theelectronic signal S5 to the compliance monitoring device 12510. In somesuch embodiments, for example, the electronic circuit system 12530 ofthe compliance monitoring device 12510 and/or the electronic circuitsystem 12970 of the medicament delivery device 12002 can be configuredto detect when the medicament delivery device is in range (e.g., whenthe patient returns home) and then transmit the electronic signal S5. Inother such embodiments, the electronic circuit system 12530 of thecompliance monitoring device 12510 can include a scanner (e.g., anoptical scanner or the like; not shown in FIGS. 24-27) such that thepatient can scan the medicament delivery device 12002 when in proximityto the compliance monitoring device 12510 such that the electroniccircuit system 12970 of the medicament delivery device 12002 cantransmit the electronic signal S5 to the electronic circuit system 12530of the compliance monitoring device 12510.

Although the medical system 12000 is shown and described above asincluding one medicament delivery device 12002, in other embodiments, amedical system can include multiple medicament delivery devices. Such asystem can be used, for example, as a part of a chronic-care medicationregimen. For example, a medical system having multiple medicamentdelivery devices can be used to manage insulin delivery or the deliveryof other medicaments (e.g., to treat Multiple Sclerosis, anemia,Rheumatoid Arthritis, Osteoporosis or the like), which can requiredaily, weekly and/or monthly injections. FIG. 28 is a schematicillustration of a medical system 14000 according to an embodiment of theinvention, that includes multiple medical injectors 14002A-14002G.Because the medical system 14000 is similar in many respects to themedical systems shown and described above, the medical system 14000 isshown in only one configuration. The medical system 14000 includes acontainer 14040, a compliance tracking device 14010 and multiple medicalinjectors 14002A-14002G. The compliance tracking device 14010 is similarto the compliance tracking device 12010 shown and described above,except that the medical injectors 14002A-14002G need not be disposedwithin the compliance tracking device 14010. The compliance trackingdevice 14010 includes an electronic circuit system 14020, which can beoperatively coupled to a computer, a communications network, or thelike, as discussed above.

The medical injectors 14002A-14002G can be, for example, single-use,disposable auto-injectors of the types shown and described herein. Insome embodiments, the medical injectors 14002A-14002G can include thesame dosage of a medicament, and can be prescribed as a part of achronic-care medicament regimen, clinical trial, or the like. In otherembodiments, the medical injectors 14002A-14002G can include thedifferent dosages and/or different medicament compositions.

Each of the medical injectors 14002A-14002G includes a removable cover14070A-14070G, a first electronic circuit system 14920A-14920G and asecond electronic circuit system 14080A-14080G. The removable covers14070A-14070G can be, for example, protective needle guards, safetylocks, or any other protective device. As shown in FIG. 28, each of thesecond electronic circuit systems 14080A-14080G is coupled to thecorresponding removable cover 14070A-14070G. The first electroniccircuit systems 14920A-14920G are coupled to the medicament injectors14002A-14002G, as shown and described above. The first electroniccircuit systems 14920A-14920G and the second electronic circuit systems14080A-14080G can each be similar in function and design to theelectronic circuit systems shown and described above. By utilizing twoelectronic circuit systems on each medical injector (e.g., the firstelectronic circuit system 14920A and the second electronic circuitsystem 14080A), the first electronic circuit systems 14920A-14920G andthe second electronic circuit systems 14080A-14080G can be cooperativelydesigned to provide the desired functionality, as described above. Inother embodiments, however, each medical injector 14002A-14002G caninclude only a single electronic circuit system.

The container 14040 includes an electronic circuit system 14050, and isconfigured to receive and/or hold at least a portion of each of themedical injectors 14002A-14002G. For example, in some embodiments, thecontainer 14040 can include multiple recessed portions, retainers,and/or any other suitable structure that matingly receives at least aportion of each medical injector 14002A-14002G. In some embodiments, themedical injectors 14002A-14002G can be arranged within the container14040 in a specific order and/or orientation. Such an arrangement can beused, for example, to facilitate the medication regimen. Said anotherway, in some embodiments, the medical injectors 14002A-14002G can bearranged in the order reflecting the order in which they are to beadministered by the user. In other embodiments, however, the medicalinjectors 14002A-14002G can be arranged within the container 14040randomly. Moreover, in some embodiments, the container 14040 can beconfigured to receive different types of medical injectors. This canallow the container 14040 to be used in both current and futuretherapeutic regimens for a patient.

The electronic circuit system 14050 of the container 14040 can besimilar to the electronic circuit systems shown and described above, andcan, for example, transmit and/or receive electronic signals from theelectronic circuit system 14020 of the compliance monitor, the firstelectronic circuit systems 14920A-14920G and/or the second electroniccircuit systems 14080A-14080G. In some embodiments, the electroniccircuit system 14050 of the container 14040 can include an RFID tagencoded with information associated with the medical injectors14002A-14002G, the medication regimen or the like. In this manner, theelectronic signals output and/or produced by the electronic circuitsystem 14050 of the container 14040 can include informationcharacterizing the medical injectors 14002A-14002G and/or the medicationregimen. Such information can include, for example, the number ofmedical injectors, the amount and type of medicament contained withineach medical injector, an expiration date of each medical injector orthe like. In this manner, when a patient receives a container 14040 foruse, the electronic circuit system 14050 of the container 14040 can beelectronically encoded with information that can received by thecompliance tracking device 14010. Accordingly, when the patientelectronically couples the container 14040 to the compliance trackingdevice 14010 (e.g., by wired connection or a wireless connection), thecontainer 14040 and the compliance tracking device 14010 canelectronically and/or automatically update the patient compliance dataassociated with the medication regimen.

In use, a container 14040 can include the medical injectors required toadminister a predetermined medication regimen. For example, in someembodiments the container 14040 can be “loaded” by a pharmacy anddelivered to the patient. The container 14040 is then operativelycoupled to the compliance tracking device 14010. Said another way, theelectronic circuit system 14050 of the container 14040 can beelectronically coupled to the electronic circuit system 14020 of thecompliance tracking device 14010. In this manner, the electronicinformation included within the electronic circuit system 14050 of thecontainer 14040 can be received by the electronic circuit system 14020of the compliance tracking device 14010 to initialize and/or update acompliance tracking schedule associated with the patient's medicationregimen.

The compliance tracking device 14010 can then produce and/or output oneor more electronic outputs, as described above. Such outputs caninclude, for example, visual and/or audible outputs reminding thepatient of the date and time of the next dosage, indicating theexpiration date of the medicament delivery device, providinginstructions in the use of the medicament delivery device, a status ofthe compliance tracking device 14010, a use instruction associated withthe compliance tracking device 14010 and/or the like.

To administer a dosage, the patient removes the appropriate medicalinjector (e.g., medical injector 14002A) from the container 14040. Insome embodiments, the removal of the medical injector 14002A triggersthe electronic circuit system 14050, the first electronic circuit system14920A and/or the second electronic circuit system 14080A to output anelectronic signal, as described above. Similarly, when the patientremoves the removable cover 14070A to place the medical injector 14002Ain a “ready” position, the first electronic circuit system 14920A and/orthe second electronic circuit system 14080A can output an electronicsignal, as described above. Finally, when the patient actuates themedical injector 14002A, the first electronic circuit system 14920Aand/or the second electronic circuit system 14080A can output anelectronic signal, as described above. In this manner, the medicalinjectors 14002A-14002G, the container 14040 and the compliance trackingdevice 14010 can cooperatively monitor the patient's compliance inadhering to the medication regimen.

Although the medical system 3000 is shown and described above asincluding a medicament delivery device 3002 that is removed from acontainer 3010 during the medicament delivery event, in otherembodiments, a medical system can include a medicament delivery devicethat remains at least partially disposed within the container during amedicament delivery event. For example, FIGS. 29-31 show a medicalsystem 13000 according to an embodiment of the invention in a firstconfiguration, a second configuration and a third configuration,respectively. The medical system 13000 includes a medicament deliverydevice 13002 and a container 13510. As shown in FIGS. 30 and 31, themedicament delivery device 13002 has a proximal end portion 13112 and adistal end portion 13114. The distal end portion 13114 includes anactuator 13970 configured to initiate the delivery of medicament fromthe medicament delivery device 13002, as described above. The medicamentdelivery device 13002 also includes an electronic circuit system 13920.The electronic circuit system 13920 of the medicament delivery device13002 can include similar components and can have similar functionalityas any of the electronic circuit systems described herein.

The container 13510 defines an internal region 13512 (see FIGS. 30 and31) and a cover 13518 (FIG. 29). The container 13510 also includes anelectronic circuit system 13530. As shown in FIGS. 30 and 31, theproximal end portion 13112 of the medicament delivery device 13002 isdisposed within the internal region 13512 of the container 13510. Insome embodiments, the internal region 13512 of the container 13510 caninclude a recessed portion, a retainer, and/or any other suitablestructure that matingly receives at least a portion of the proximal endportion 13112 of the medicament delivery device 13002. In this manner,the medicament delivery device 13002 can be maintained within thecontainer 13510 during use.

The cover 13518 is removably coupled to the container 13510. When thecover 13518 is coupled to the container 13510, the distal end portion13114 of the medicament delivery device 13002 is within the cover 13518.In this manner, the cover 13518 can protect the medicament deliverydevice 13002 and/or prevent the inadvertent use thereof. In someembodiments, the cover 13518 can be coupled to the container 13510 viaan interference fit, a threaded coupling, a mating protrusion and recesscoupling, or the like.

The electronic circuit system 13530 of the container 13510 includes atleast a switch 13536 and a communications port 13531. The switch 13536,which can be similar to the switch 12536 shown and described above,produces an electronic input to the electronic circuit system 13530 whenthe cover 13518 is removed from the container 13510. Said another way,the electronic circuit system 13530 is configured to produce and/oroutput one more electronic signals when the switch 13536 changes statesin response to the cover 13518 being removed from the container 13510.For example, as shown in FIG. 30, in some embodiments, the electroniccircuit system 13530 is configured to produce and/or output a firstelectronic signal S2′ when the switch 13536 changes states (e.g., whenthe cover 13518 is removed from the container 13510). The firstelectronic signal S2′ can be similar to any of the electronic signalsand/or outputs described herein.

The communications port 13531 can be any suitable port for operativelycoupling the electronic circuit system 13530 of the container 13510 to aremote device, such as a compliance monitoring device, a PC, a batterycharger, or the like (not shown in FIGS. 29-31). The remote device canbe coupled to the communications port 13531 via an electronic cable13532 configured to be matingly coupled to the communications port13531. In some embodiments, the internal region 13512 of the container13510 can include a port and/or electronic coupling (not shown in FIGS.29-31) such that the electronic circuit system 13920 of the medicamentdelivery device 13002 can be operatively coupled to the electroniccircuit system 13530 of the container 13510 when the proximal endportion 13112 of the medicament delivery device 13002 is disposed withinthe container 13510. In this manner, the container 13510 can function asa docking station for the medicament delivery device 13002. Said anotherway, the electronic circuit system 13920 of the medicament deliverydevice 13002 can be powered by and/or use certain components of theelectronic circuit system 13530 of the container 13510. Such anarrangement can facilitate the use of a low-cost electronic circuitsystem on a single-use, disposable medicament delivery device.

To move the medical system 13000 from the first configuration to thesecond configuration (i.e., a “pre-delivery” configuration), the cover13518 is removed from the container 13510, as shown by the arrow RR inFIG. 29. When the cover 13518 is removed from the container 13510, theelectronic circuit system 13530 of the container 13510 produces thefirst electronic signal S2′. The first electronic signal S2′ can beassociated with the prescribed medication regimen (including, forexample, compliance data), an identification of the medicament deliverydevice 13002, a status of the medicament delivery device 13002, a useinstruction associated with the medicament delivery device 13002, astatus of the container 13510, a use instruction associated with thecontainer 13510 and/or the like. In some embodiments, for example, thefirst electronic signal S2′ can include a visual output, an audibleoutput and/or a haptic output that instructs and/or provides cues to auser in the use of the container 13510 to track the patient'scompliance. In other embodiments, the first electronic signal S2′ caninclude a communications signal that can be transmitted via the port15531 and/or by wireless transmission to a remote device (not shown inFIGS. 29-31).

To move the medical system 13000 from the second configuration to thethird configuration (i.e., a “post-delivery” configuration), themedicament delivery device 13002 is actuated by moving the actuator13970 as shown by the arrow SS in FIG. 31. The patient can move theactuator 13970, for example, by gripping the container 13510 andpressing the distal end portion 13114 of the medicament delivery device13002 against the body. When the actuator 13970 is moved from the firstposition to the second position, actuation of the medicament deliverydevice is initiated. Moreover, when the actuator 3970 is moved, theelectronic circuit system 13920 of the medicament delivery device 13002outputs the second electronic signal S3′.

The second electronic signal S3′ is received by the electronic circuitsystem 13530 of the container 13510, which then produces the thirdelectronic signal S4′. As described above, the third electronic signalS4′ is associated with the second electronic signal S3′. The electronicsignals S3′ and S4′ can be similar to the electronic signals S3 and S4described above with reference to FIGS. 20-22. For example, in someembodiments, the electronic signal S3′ can include a time stampassociated with the actuation of the medicament delivery device 13002,and the electronic signal S4′ can include information associated withthe dosage, contents and/or status of the medicament delivery device13002.

In this manner, the electronic circuit system 13530 of the container13510 and the electronic circuit system 13920 of the medicament deliverydevice 13002 can cooperatively monitor the patient's compliance in usingthe medicament delivery device 13002. By utilizing two electroniccircuit systems, the electronic circuit system 13920 and the electroniccircuit system 13530 can be cooperatively designed to provide thedesired functionality. For example, in some embodiments, the container13530 can be a reusable compliance tracking device and the medicamentdelivery device 13002 can be a single-use, disposable device. Uponcompletion of the injection, the patient can subsequent re-load thecontainer 13510 with next medicament delivery device 13002, asprescribed.

Although the electronic circuit systems disposed on the medicamentdelivery devices are shown and described above as outputting anelectronic signal in response to the movement of an actuator, in otherembodiments, an electronic circuit system can be configured to prevent,eliminate, reduce and/or alter the transmission of an electronic signalin response to the actuation of the medicament delivery device. Forexample, FIGS. 32 and 33 are schematic illustrations of a medicamentdelivery device 5002 according to an embodiment of the invention, in afirst configuration and a second configuration, respectively.

The medicament delivery device 5002, which can be medical injector(e.g., an auto-injector, a pen injector, a multiple-use injector, asyringe or the like), an inhaler or the like, includes an actuator 5970and an electronic circuit system 5920. The actuator 5970 is movablebetween a first position (FIG. 32) and a second position (FIG. 33). Whenthe actuator 5970 is moved from the first position to the secondposition, the actuator 5970 initiates the delivery of the medicamentinto the body. In some embodiments, for example, the actuator 5970 canbe configured to release a spring, an energy storage member, or thelike, to initiate medicament delivery when the actuator 5970 is movedfrom the first position to the second position.

The electronic circuit system 5920 includes at least a first RFID tag5921 and a second RFID tag 5923. The first RFID tag 5921 is configuredto output a first electronic signal S6, which can be received by acompliance monitoring device (not shown in FIGS. 32 and 33) of the typesshown and described herein. Similarly, the second RFID tag 5923 isconfigured to output a second electronic signal S7, which can bereceived by a compliance monitoring device. The first electronic signalS6 has an electronic characteristic (e.g., frequency, amplitude, etc.)that is different from an electronic characteristic of the secondelectronic signal S7. In this manner, a receiving device (e.g., acompliance monitoring device) can distinguish the first electronicsignal S6 from the second electronic signal S7.

To deliver a dose of medicament, the patient moves the actuator 5970from the first position to the second position, as shown by the arrow OOin FIG. 33. When the actuator 5970 is moved from the first position tothe second position, actuation of the medicament delivery device 5002 isinitiated. Said another way, the actuator 5970 is configured to initiatedelivery of the medicament when the actuator 5970 is moved from thefirst position to the second position.

When the actuator 5970 is moved from the first position to the secondposition, the actuator 5970 eliminates, blocks, and/or alters the secondelectronic signal S7, as indicated by the arrow PP in FIG. 33. In thismanner, the receiving device (e.g., a compliance monitoring device) canreceive electronic feedback from the electronic circuit system 5920corresponding to the actuation of the medicament delivery device 5002.Moreover, the electronic feedback (i.e., the elimination, blockage,and/or alteration of the second electronic signal S7) is providedwithout requiring the patient to execute any additional steps, otherthan those required to actuate the medicament delivery device 5002. Inthis manner, the medicament delivery device 5002 is configured toelectronically and/or automatically track the details of its use.

When the actuator 5970 is moved from the first position to the secondposition, the first electronic signal S6 is not changed. Accordingly,the first electronic signal S6 can function as a validation signal tothe receiving device during the actuation of the medicament deliverydevice 5002. Said another way, the electronic signal S6 can providefeedback associated with the functionality of the electronic circuitsystem 5920 (e.g., that the first electronic circuit system 5920 iswithin the transmission range of the receiving device, that the firstelectronic circuit system is receiving power, etc.).

The actuator 5970 can eliminate, block, and/or alter the secondelectronic signal S7 by any suitable mechanism. For example, in someembodiments, the movement of the actuator 5970 produces an input that isreceived by the electronic circuit system 5920, thereby triggering theelectronic circuit system 5920 to eliminate, block, and/or alter thesecond electronic signal S7 output by the second RFID tag 5923. Saidanother way, in some embodiments, the movement of the actuator 5970 canchange the state of a switch (not shown in FIGS. 32 and 33) within theelectronic circuit system 5920 thereby triggering the electronic circuitsystem 5920 to eliminate, block, and/or alter the second electronicsignal S7 output by the second RFID tag 5923.

In other embodiments, the movement of the actuator 5970 can disrupt atleast a portion of the second RFID tag 5923, thereby eliminating,blocking, and/or altering the second electronic signal S7. For example,in some embodiments, the movement of the actuator 5970 can separate,tear, deform and/or sever a portion of the second RFID tag 5923. Inother embodiments, the movement of the actuator 5970 can electronicallyshield a portion of the second RFID tag 5923, thereby eliminating,blocking, and/or altering the second electronic signal S7. For example,in some embodiments, the actuator 5970 can include a shield portionconfigured to be disposed about the second RFID tag 5923 when theactuator is in the second position. Such a shield can, for example,block the signal S7 from being output by the second RFID tag 5923.

In other embodiments, the movement of the actuator 5970 canelectronically decouple a power source (not shown in FIGS. 32 and 33)from a portion of the electronic circuit system 5920 and/or the secondRFID tag 5923. For example, in some embodiments, the actuator 5970 caninclude a battery isolation tab (not shown in FIGS. 32-33) configured toisolate a battery from a portion of the electronic circuit system 5920.In other embodiments, the actuator 5970 can include a shield portionconfigured to be disposed about the second RFID tag 5923 when theactuator is in the second position. In this manner, the shield canprevent the second RFID tag 5923 from receiving power from a remotesource (e.g., a master RFID tag disposed on the receiving device).

As described herein, the first electronic signal S6 and/or the secondelectronic signal S7 can include information characterizing the firstmedicament delivery device 5002. For example, in some embodiments, thefirst electronic signal S6 and/or the second electronic signal S7 can beassociated with the contents of the medicament delivery device 5002(e.g., the amount and type of medicament contained therein), anexpiration date of the medicament delivery device 5002, a dosage of themedicament delivery device 5002 and/or a use instruction associated withthe medicament delivery device 5002. In this manner, the receivingdevice (not shown in FIGS. 32 and 33) can produce the electronic outputsassociated with information contained within the first electronic signalS6 and/or the second electronic signal S7. Said another way, thisarrangement allows the receiving device to produce an electronic outputthat is unique to the medicament delivery device 5002.

In some embodiments, the first RFID tag 5921 and/or the second RFID tag5923 can be passive RFID tags. In such an arrangement, the first RFIDtag 5921 and/or the second RFID tag 5923 can be powered remotely by aparent RFID tag, which can be disposed, for example on a compliancemonitoring device (not shown in FIGS. 32 and 33). In this manner, theelectronic circuit system 5920 of the medicament delivery device 5002can be devoid of a power supply (e.g., a battery or any other energystorage device). Accordingly, the electronic circuit system 5920 can bea simple, low-cost circuit system 5920 that is suitable for use on asingle-use, disposable medicament delivery device.

Although the medicament delivery devices are shown and described aboveas outputting an electronic signal in response to the movement of anactuator, in other embodiments, a medicament delivery device can includeany suitable means for providing feedback associated with a dosageadministration event. Moreover, although the electronic circuit system1920 shown and described above with reference to FIGS. 1-3 include aproximity sensor 1974 to provide feedback associated with the validityof an injection event, in other embodiments, a medicament deliverydevice can include any suitable feedback mechanism for providingfeedback associated with the validity of a medicament delivery event.For example, FIGS. 34 and 35 are schematic illustrations of a medicalinjector 15002 according to an embodiment of the invention, in a firstconfiguration and a second configuration, respectively.

The medical injector 15002, which can be, for example, a single-use,disposable auto-injector of the types shown and described herein,includes a housing 15110, a medicament container 15262, a needle 15212,and an electronic circuit system 15920. The housing 15110 has a proximalend portion 15112 and a distal end portion 15114. The medicamentcontainer 15262 is disposed within the housing 15110. Although themedicament container 15262 is shown as being movably disposed within thehousing 15110, in other embodiments, the medicament container 15262 canbe fixedly disposed within the housing 15110.

The needle 15212 includes a proximal end 15216 and a distal end 15214,and is configured to be in fluid communication with the medicamentcontainer 15262. In this manner, the medicament within the medicamentcontainer 15262 can be conveyed into a body during an injection eventvia the needle 15212. The needle 15212 is movably disposed within thehousing 15110 between a first position (FIG. 34) and a second position(FIG. 35). When the needle 15212 is in the first position, the distalend 15214 of the needle is disposed within the housing 15110. When theneedle 15212 is in the second position, the distal end 15214 of theneedle is disposed outside of the housing 15110. Accordingly, when themedical injector 15002 is actuated, the needle 15212 can be movedbetween the first position and the second position to penetrate thepatient's skin S (see FIG. 35) and/or provide a passageway fordelivering the medicament into the patient's body B.

The electronic circuit system 15920 is includes at least a firstelectrode 15030 and a second electrode 15031. The first electrode 15030is disposed at the distal end 15214 of the needle 15212. The secondelectrode 15031 is disposed at the distal end portion 15114 of thehousing 15110. The electronic circuit system 15920 is configured tooutput an electronic signal S8 associated with an impedance between thefirst electrode 15030 and the second electrode 15031. The electronicsignal S8 can be any suitable communications signal, of the typesdescribed herein, configured to be received by a compliance monitoringdevice (not shown in FIGS. 34 and 35) of the types shown and describedherein. In this manner, as described in more detail below, theelectronic circuit system 15920 can provide electronic and/or automaticfeedback associated with the validity and/or administration of aninjection event based on the impedance between the first electrode 15030and the second electrode 15031.

To deliver a dose of medicament, the patient first places the distal endportion 15114 of the housing against the skin S of the body B. In someembodiments, the second electrode 15031 can include a proximity sensor,similar to the proximity sensor 1974 shown and described above withreference to FIGS. 1-3. Accordingly, in such embodiments, the electroniccircuit system 15920 can produce one or more electronic outputsindicating that the medical injector 15002 is properly positioned andready to be actuated. The patient then actuates the medical injector15002 thereby causing the needle to move from the first position to thesecond position, as shown by the arrow QQ in FIG. 35. Accordingly, theneedle penetrates the patient's skin S to provide a passageway fordelivering the medicament into the patient's body B.

During the above-described injection event, the electronic circuitsystem 15920 is configured to measure the impedance Z₁ between the firstelectrode 15030 and the second electrode 15031. The electronic circuitsystem 15920 can then produce and/or output the electronic signal S8,which is associated with the impedance Z₁. In some embodiments, theelectronic signal S8 can be processed, either by the electronic circuitsystem 15920 or by a compliance monitoring device (not shown in FIGS. 34and 35) to characterize the validity of the injection event. Forexample, based on the impedance Z₁, the known depth of penetration ofthe needle 15212 (i.e., the distance between the distal end 15114 of thehousing 15110 and the distal end 15214 of the needle 15212), and/or thecharacteristic impedance of various types of bodily tissue, a compliancemonitoring device can determine whether the needle 15212 was disposedwithin bodily tissue T during the injection event. Said another way,because bodily tissue T has a characteristic impedance that is differentfrom a characteristic impedance of other materials (e.g., a pillow,drywall, clothing materials or the like), the compliance monitoringdevice can evaluate the validity of the injection event based on theimpedance Z₁ and/or the known depth of penetration of the needle 15212.Moreover, because different types of bodily tissue can have differentcharacteristic impedance values, in some embodiments, the compliancemonitoring device can evaluate whether the injection occurred withinfatty tissue, muscle tissue, bone tissue or the like.

Although the medicament delivery devices, containers and/or compliancetracking devices shown and described above can be configured to sendand/or receive electronic signals associated with a wide range ofinformation, in some embodiments, a medicament delivery device, acontainer and/or a compliance tracking device can include a wirelesscommunications system configured to transmit a location of themedicament delivery device. Such embodiments, can be particularlyappropriate, for example, when the medicament delivery device is asingle-dose device for use in emergency situations. For example, FIG. 36is a schematic illustration of a medicament delivery device 8002according an embodiment of the invention that includes a wirelesscommunications system 8985 configured to communicate electronicallydirectly with an emergency response dispatcher 8990E, via wirelessnetwork N_(W) as described above. Moreover, the wireless communicationssystem 8985 includes a Global System for Mobile Communications and/orGlobal Positioning System (GPS) enabled feature, which can include atransmitter, a receiver, software, hardware and/or other electronics(not shown in FIG. 36) to transmit the geographical location of themedicament delivery device 8002 to the emergency response dispatcher8990E. In this manner, when the medicament delivery device 8002 is used,it can be configured to automatically notify emergency responsepersonnel (Emergency Medical Technicians, Fire, Police and the like).

In some embodiments, a wireless communications system can be configuredto transmit the geographical location of the medicament delivery deviceto an emergency response dispatcher via a wireless communications devicethat is GPS-enabled. For example, FIG. 37 is a schematic illustration ofa medicament delivery device 9002 according an embodiment of theinvention that includes a wireless communications system 9985 configuredto transmit the geographical location of the medicament delivery device9002 via a wireless communications device 9990C that is GPS-enabled. Forexample, in some embodiments, the GPS-enabled wireless communicationsdevice 9990C can be a cellular phone. In this manner, when themedicament delivery device 9002 is actuated, the wireless communicationssystem 9985 transmits data to the GPS-enabled cell phone 9990C, asdescribed above. The GPS-enabled cell phone 9990C automatically dials anemergency number such as, for example, 911 (emergency dispatcher),and/or sends information associated with the location of the medicamentdelivery device 9002 and/or the end user location through GPS satellitepositioning or network based positioning (using cell phone towers).

Although the wireless communications systems are shown and describedabove as being configured to send and/or receive electronic signalsassociated with a wide range of information, in some embodiments, awireless communications system can be configured to send and/or receiveelectronic signals associated with the actuation of a medicamentdelivery device. More particularly, in some embodiments a wirelesscommunications system can be employed to remotely trigger variousfunctions of a medicament delivery device. For example, FIG. 38 is aschematic illustration of a medicament delivery device 10002 accordingto an embodiment of the invention that includes such functionality. Themedicament delivery device 10002 includes a wireless communicationssystem 10985 and an actuator 10995. The wireless communications system10985, which can be any suitable system of the type shown and describedabove is operatively coupled to the actuator 10995. The actuator 10995can be any suitable mechanism configured to receive an input from thewireless communications system 10985 and, based upon the input, triggera function of the medicament delivery device 10002. For example, in someembodiments, the actuator 10995 can be integrated into the wirelesscommunications system 10985. The actuator can include, for example, aprogrammable logic controller (PLC) and/or solenoid that allow the datareceived via the wireless communications system 10985 to be convertedinto an action to actuate the medicament delivery device 10002. Forexample, in some embodiments, as described in more detail herein, themedicament delivery device 10002 can be a gas-powered auto-injector andthe actuator 10995 can be configured to move a compressed gas cylinderto actuate the auto-injector.

In use, the remote actuation feature of the medicament delivery device10002 can be advantageous in circumstances in which the user of such adevice is not able to actuate the medicament delivery device 10002and/or there are no other individuals present to actuate the medicamentdelivery device 10002. For example, in certain situations, soldiers on abattlefield can carry the medicament delivery device 10002, which cancontain one or more medicaments. Such medicaments can be formulated torelieve acute pain (e.g., morphine), mitigate the effects of exposure toa nerve agent and/or prevent seizures secondary to such exposure. Thewireless communications system 10985 can be configured to sendinformation to and/or receive information from a battlefield monitorstation 10990B located in a secure area. In this manner, the battlefieldmonitor station 10990B can monitor and/or be in communication with thesoldiers on the battlefield.

When a critical incident occurs requiring the use of the medicamentdelivery device 10002, monitoring personnel can send a signal from thebattlefield monitor station 10990B to the medicament delivery device10002 on the soldier requiring medical attention. The wirelesscommunications system 10985 can receive the signal and process thesignal into “activation” data, which can then be transmitted to theactuator 10995 to trigger the actuation of the medicament deliverydevice 10002 and subsequent delivery of the required medication and/oragent. To ensure that the medicament is delivered in the desiredlocation within the soldier's body, the medicament delivery device 10002can be placed in a predetermined orientation relative to the soldier.For example, in some embodiments, the medicament delivery device 10002can be retained within a specific pocket of the soldier's uniform.

Although the medicament delivery devices have been shown and describedabove as including a wireless communications system, in someembodiments, a medicament delivery device can send signals to and/orreceive signals from various communications devices using a combinationof communications networks. For example, in some embodiments, amedicament delivery device can send signals to and/or receive signalsfrom various communications devices using any suitable combination ofwireless networks and wired networks. For example, FIG. 39 is aschematic illustration of a medicament delivery device 11002 accordingto an embodiment of the invention that includes an electronic circuitsystem 11920 and an electronic communications port 11996. The electroniccircuit system 11920 can be any electronic circuit system of the typeshown and described herein. For example, the electronic circuit system11920 can be configured to monitor the status of the medicament deliverydevice 11002, actuate the medicament delivery device 11002, provideinstructions for using the medicament delivery device 11002 or the like.

The electronic communications port 11996 can be any device configured tobe operatively coupled to a docking station 11997, which is in turnoperatively coupled via a communications network N to a communicationsdevice 11990. The docking station 11977 can be, for example, acompliance monitoring device and/or a container of the types shown anddescribed herein. The communications device 11990 can be anycommunications device of the type shown and described above (e.g., aphysician's computer, PDA, an insurer's computer, etc.). In this manner,the electronic circuit system 11920 can send electronic signals toand/or receive electronic signals from the communications device 11990via the communications network N and the docking station 11997.Moreover, as described herein, the docking station 11997 can include anelectronic circuit system (not shown in FIG. 39) to store, processand/or produce electronic signals associated with the use of themedicament delivery device 11002. The communications network N can beany suitable communications network, and can include, for example, wirednetworks.

In some embodiments, the electronic communications port 11996 can be aserial bus port such as a USB ports or any another method of connectingthe electronic circuit system 11920 to the docking station 11997 and/orthe communications device 11990 to transfer data. The electronic circuitsystem 11920, the electronic communications port 11996 and/or thedocking station 11997 can include any electronic components (includinghardware, firmware and/or software) configured to facilitate electroniccommunication. For example, in some embodiments, the electronic circuitsystem 11920, the electronic communications port 11996 and/or thedocking station 11997 can include Small Computer System Interface (SCSIand ports), FireWire (or other IEEE 1394 interfaces), data uplink,point-to-point link, fiber optic links, hard drives, pc cards, circuitboards, uplinks, downlinks, docking stations, parallel and bit-serialconnections, and the like.

In some embodiments, the use of a wired communication system used as apart of the communications path, can improve the reliability of theinformation being transferred and could ensure that the information istransferred at the right time and efficiently. For example, after apatient uses the medicament delivery device 11002, the user can placethe device into the docking station 11997 connected to the user'sworkstation (i.e., the communications device 11990 to trigger thetransfer of information.

Moreover, as described above, in some embodiments, the communicationsdevice 11990 can include software and/or hardware to download theinformation from the medicament delivery device to the workstation andtransmit such information to a third party such as the patient's/user'shealth care provider (not shown in FIG. 39). As described above, suchinformation could include the location where the device was activated,time of day, dosage and route of administration, frequency of deviceusage, functionality of the device once used, expiration date of thedevice, device status, medicament status, and any adverse eventexperienced by the user following the use of the device. Moreover, asdescribed above, after the information is sent, the user can be notifiedthat the information was sent successfully by receiving electronicconfirmation from the communications device 11990 and/or the third partydevices. The illustrated communication system also allows the patient toconnect to his or her workstation and download information to themedicament delivery device. Such information can include, for example,updated dosing information, updated use instructions, critical softwareupdates, and other information that would be useful to the patient. Themedicament delivery device could also connect to other devices otherthan just a workstation or docking station such as a mini USB drive totransfer the information.

The electronic circuit systems shown and described above can include oneor more electronic components operatively coupled to perform thefunctions described herein For example, the electronic circuit systemsshown and described herein (including those included as a part of themedicament delivery devices, the containers, and the compliancemonitoring devices shown and described herein) can be similar to theelectronic circuit system 1920 shown and described above with referenceto FIG. 3. Although the medical devices shown and described aboveinclude one electronic circuit system, in some embodiments, a medicaldevice can include multiple electronic circuit systems configured toperform the functions described herein.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although the components included in the electronic circuitsystem 4920 (e.g., the microprocessor 4950, the LEDs 4958A and 4958B orthe like) are shown and described as being operatively coupled byelectrical conductors 4934, in other embodiments, the components can beoperatively coupled without being physically connected. For example, insome embodiments, at least a portion of the components included in anelectronic circuit system can be inductively coupled. In otherembodiments, at least a portion of the components included in anelectronic circuit system can be evanescently coupled.

Although the switches 4972A and 4972B are shown and described as being“tear-through” switches that are monolithically formed from theelectrical conductors 4934, in other embodiments, a switch can be formedseparately from the electrical conductors 4934. For example, in someembodiments, an electrical circuit system can include a series of firstelectrical conductors having a first set of characteristics (e.g., thewidth, height, material from which the conductor is fabricated or thelike) and a switch constructed from a second electrical conductor havinga second set of characteristics different than the first set ofcharacteristics. In other embodiments, a switch can be a separatecomponent, such as, for example, a microswitch, that is mounted to theprinted circuit board. In yet other embodiments, an electrical circuitsystem can include a “pop-out” switch that includes a biasing member tobias the switch in a predetermined state. In yet other embodiments, anelectrical circuit system can include a switch that is disposed at alocation other than on a printed circuit board.

Similarly, although the switches 4972A and 4972B are shown and describedas being irreversibly movable from a first state to a second state, inother embodiments, a switch can be reversibly movable between a firststate and a second state. Moreover, in yet other embodiments, a switchcan have more than two distinct states.

Although the actuators 4732, 4539 are shown and described as beingconfigured to move in a direction substantially parallel to the surfaceof the substrate 4924, in other embodiments, an actuator can beconfigured to actuate an electronic circuit system by moving in anydirection. For example, in some embodiments a circuit actuator can bemoved in a direction substantially normal to a portion of an electroniccircuit system.

Similarly, although the actuators 4732, 4539 are shown and described asactuating the switches 4972A and 4972B by tearing and/or deforming aportion of the substrate 4924, in other embodiments, a switch can bemoved from a first state to a second state without deforming thesubstrate. For example, in some embodiments, an electronic circuitsystem can include a printed circuit board having a substrate and afrangible switch tab disposed on the substrate. An electrical conductorand/or a switch can be disposed on the frangible switch tab, such thatwhen the switch tab is removed from the substrate the switch is movedfrom a first state to a second state. In this manner, the switch can beactuated without tearing and/or deforming a portion of the substrate.

Although the actuators 4732, 4539 are shown and described as beingincluded on the safety lock 4710 and the base 4520, respectively, inother embodiments, the actuators can be included on any component of amedicament delivery device. For example, in some embodiments, anauto-injector can include a start button having an actuator configuredto actuate an electronic circuit system. In other embodiments, anauto-injector can include a movable member configured to move amedicament container and/or a needle within a housing of theauto-injector, the movable member including an actuator configured toactuate an electronic circuit system.

Although the safety lock 4710 is shown and described as being removedfrom the housing 4110 of the auto-injector 4002 when in its secondposition, in other embodiments, a safety lock can remain coupled to thehousing of an auto-injector when in its second position. For example, insome embodiments, a safety lock can be moved from its first position toits second position by rotating a portion of the safety lock.

Certain components of the auto-injector 4002 are shown and described asbeing coupled together via protrusions and mating openings. Theprotrusions and/or openings can be disposed on any of the components tobe coupled together and need not be limited to only a certain component.For example, the safety lock 4710 is shown and described as including anactuator 4732 having a protrusion 4730 configured to be received withinan opening 4928A defined by the substrate 4924. In some embodiments,however, the protrusions can be disposed on the substrate 4924 and themating openings can be defined by the actuator 4732. In otherembodiments, such components can be coupled together in any suitableway, which need not include protrusions and mating openings. Forexample, in some embodiments, an actuator can be operatively coupled toan actuation portion of a substrate via mating shoulders, clips,adhesive or the like.

Although the medical system 14000 shown as including a container 14040,a compliance tracking device 14010 and multiple medical injectors14002A-14002G, each having at least one electronic circuit system (seee.g., electronic circuit systems 14050, 14020, 14080 and 14920), in someembodiments, a medical system can include only a container havingmultiple medical injectors. In such embodiments, the container can be atray or other device configured to hold the medical injectors. Thecontainer can also perform the functions of the compliance monitoringdevice 14010, as described above. Moreover, in some embodiments, amedical injector can include a sheath similar to sheath 14070, whereinthe sheath performs the electronic functions of the compliancemonitoring device 14010 and/or the container 14050, as described above.

Although the electronic circuit systems are shown and described above asoutputting recorded speech in English, in other embodiments, theelectronic circuit system can output recorded speech in any language. Inyet other embodiments, the electronic circuit system can output recordedspeech in multiple languages.

Although some of the electronic circuit systems are shown and describedabove as including a proximity sensor, in other embodiments, anelectronic circuit system can include any suitable sensor for providingfeedback to the electronic circuit system. For example, in someembodiments, an electronic circuit system can include a pressure sensorconfigured to sense the internal gas pressure within a gas-poweredauto-injector. In this manner, the electronic circuit system can outputan instruction, a status message, and/or an electronic signal to acompliance tracking device when the internal gas pressure crosses apredetermined threshold. For example, in some embodiments, when theinternal gas pressure rapidly increases, the electronic circuit systemcan output a message, such as, for example, “Internal gas chamber hasbeen successfully punctured—injection is in process.”

Similarly, in some embodiments, an electronic circuit system can includea temperature sensor configured to sense the temperature of themedicament contained within the medicament delivery device. In thismanner, the electronic circuit system can output an instruction, astatus message and/or an electronic signal to a compliance trackingdevice when the medicament is too cold for effective delivery. Forexample, in some embodiments, when the medicament is too cold foreffective delivery (this may occur, for example, if the medicamentdelivery device has been left outside overnight or refrigerated forstorage), the electronic circuit system can output a message, such as,for example, “MEDICAMENT IS TOO COLD—PLEASE BRISKLY RUB THEAUTO-INJECTOR BETWEEN YOUR HANDS.” Similarly, in some embodiments, theelectronic circuit system can output a message and/or a signal basedupon the feedback from the temperature sensor, for example, indicatingwhen the medicament will be at the appropriate temperature for delivery.For example, in some embodiments, the electronic circuit system canoutput a message stating “THE CURRENT MEDICAMENT TEMPERATURE IS XXDEGREES. PLEASE ALLOW THE MEDICAMENT TO STAND AT ROOM TEMPERATURE FORAPPROXIMATELY XX MINUTES BEFORE ADMINISTERING THE DOSE. PLEASE DO NOTMICROWAVE OR OTHERWISE HEAT THE MEDICAMENT.” Similarly, in someembodiments, the electronic circuit system can output an electronicsignal to a compliance tracking device so that the temperature data canbe stored and/or transmitted to a remote device, as described herein.

Although the medicament delivery device 5002 is shown and describedabove as having an electronic circuit system 5920 including a first RFIDtag 5921 and a second RFID tag 5923, in other embodiments, a medicamentdelivery device can have an electronic circuit system 5920 includingonly one RFID tag. Similarly, although the signal S6 output by the firstRFID tag 5921 is shown and described above as having a characteristicdifferent from the signal S7 output by the second RFID tag 5923, inother embodiments, the signal S6 can be the same as the signal S7.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments, amedicament delivery device can include an electronic circuit systemconfigured to produce a first electronic signal when the device isactuated, similar to the medicament delivery device 3002, and a secondelectronic signal based upon the impedance between various portions ofthe device, similar to the medicament delivery device 15002.

What is claimed is:
 1. An apparatus, comprising: an electronics housinghaving a distal end surface defining an opening within which anon-delivery end portion of a medicament delivery device is removablyreceived, the medicament delivery device including a medicamentcontainer and a container housing, a distal end portion of the containerhousing having a contact portion configured to contact a target locationof a body during a medicament delivering event the electronics housingconfigured to be matingly coupled to the non-delivery end portion and toremain coupled to the medicament delivery device such that themedicament delivery device is actuated by moving the electronics housingrelative to the contact portion to initiate movement of the medicamentcontainer within a proximal end portion of the container housing, theelectronics housing configured to surround a perimeter of thenon-delivery end portion and extend along only a portion of a length ofthe medicament delivery device such that the contact portion remainsoutside of the electronics housing before and during actuation of themedicament delivery device; and an electronic circuit system coupled tothe electronics housing, the electronic circuit system including acircuit board, a processor, a switch, a light output device, and awireless communication antenna, the switch coupled to the circuit boardsuch that the switch remains spaced apart from the contact portionduring actuation of the medicament delivery device, the electroniccircuit system configured to produce a light output via the light outputdevice in response to an electronic signal produced by the switch, theelectronic circuit system configured to receive an actuation signalassociated with the actuation of the medicament delivery device, theelectronic circuit system configured to output, via the wirelesscommunication antenna, a compliance signal associated with the actuationsignal, the compliance signal being a short-range radio frequency signalincluding a time stamp associated with the actuation of the medicamentdelivery device.
 2. The apparatus of claim 1, further comprising: acover configured to be removably coupled about the distal end portion ofthe container housing to cover the contact portion, a portion of thecover configured to engage the switch such that the switch is moved fromthe first state to the a second state when the cover is removed fromabout the distal end portion of the container housing.
 3. The apparatusof claim 1, wherein the electronic circuit system includes a speaker,the electronic circuit system configured to produce a recorded speechoutput via the speaker when the switch is changed from a first state toa second state.
 4. The apparatus of claim 1, wherein the compliancesignal has a frequency between approximately 2400 MHz and approximately2480 MHz.
 5. The apparatus of claim 1, wherein the compliance signalincludes any of a unique identification of the electronics housing, anindicator associated with a validity of a medicament delivery event, ora location associated with the medicament delivery device.
 6. Theapparatus of claim 1, wherein the electronics housing includes acommunication port configured to couple the electronic circuit system toany one of a battery charger or a remote computing device via ahard-wired connection.
 7. The apparatus of claim 1, wherein t actuationsignal is produced by the switch.
 8. The apparatus of claim 1, whereinthe actuation signal is produced by a pressure sensor.
 9. The apparatusof claim 1, wherein: the actuation signal is a wireless signal producedby the medicament delivery device; and the wireless communicationantenna of the electronic circuit system is configured to receive theactuation signal.
 10. The apparatus of claim 1, wherein the electroniccircuit system includes a battery, the electronic circuit systemconfigured to produce an indication associated with a life of thebattery.
 11. The apparatus of claim 1, wherein the medicament deliverydevice is any one of an autoinjector, a pen injector or an inhaler. 12.The apparatus of claim 1, wherein the electronics housing includes aretention portion configured to matingly receive the non-delivery endportion of the medicament delivery device to maintain the non-deliveryend portion of the medicament delivery device within the electronicshousing when the medicament delivery device is actuated by manipulatingthe electronics housing.
 13. The apparatus of claim 1, wherein: themedicament delivery device is a first medicament delivery device; andthe electronics housing is configured to be removed from the firstmedicament delivery device such that a non-delivery end portion of asecond medicament delivery device can be received within the opening ofthe electronics housing.
 14. The apparatus of claim 1, wherein theswitch includes any one of an irreversible switch, a reversible switch,a two-state switch, a switch having more than two states, or a sensorconfigured to produce the electronic signal.
 15. The apparatus of claim1, wherein the container housing is distinct from the electronicshousing.
 16. The apparatus of claim 1, wherein: the electronic signal isa first electronic signal transmitted to the processor; and theelectronic circuit system includes a pressure sensor configured totransmit a second electronic signal to the processor in response to apressure exerted on the pressure sensor.
 17. An apparatus, comprising:an electronics housing including a retention portion configured tomatingly receive a non-delivery end portion of a first medicamentdelivery device such that the non-delivery end portion remains fixedwithin the electronics housing during a medicament delivery event, thefirst medicament delivery device including a medicament container and acontainer housing, a delivery end portion of the first medicamentdelivery device including a contact member coupled to the containerhousing and configured to contact a target location of a body during themedicament delivery event, the electronics housing configured to extendalong only a portion of the first medicament delivery device such thatthe contact member is outside of the electronics housing before andduring the medicament delivery event, the electronics housing configuredsuch that the first medicament delivery device is actuated by moving theelectronics housing relative to the contact member to cause themedicament container to move within the container housing, theelectronics housing configured to be removed from the first medicamentdelivery device such that the retention portion can matingly receive anon-delivery end portion of a second medicament delivery device; and anelectronics circuit system coupled to the electronics housing, theelectronic circuit system including at least one of a switch or asensor, the electronic circuit system including a light output deviceand a wireless communications module, the at least one of the switch orthe sensor positioned to remain physically separated from the contactmember when the first medicament delivery device is actuated, theelectronic circuit system configured to produce a light output via thelight output device when the at least one of the switch or the sensor ischanged from a first state to a second state, the electronic circuitsystem configured to output via the wireless communications module acompliance signal associated with the actuation of the first medicamentdelivery device, the compliance signal being a short-range radiofrequency signal.
 18. The apparatus of claim 17, wherein the electronicshousing is configured to be disposed about the non-delivery end portionof the first medicament delivery device, the electronics housingconfigured to remain coupled to the first medicament delivery devicewhen the first medicament delivery device is actuated.
 19. The apparatusof claim 17, wherein the compliance signal has a frequency betweenapproximately 2400 MHz and approximately 2480 MHz.
 20. The apparatus ofclaim 17, wherein the first medicament delivery device is any one of anautoinjector, a pen injector or an inhaler.
 21. The apparatus of claim17, wherein the retention portion of the electronics housing defines anopening within which the non-delivery end portion of the firstmedicament delivery device is disposed.
 22. The apparatus of claim 17,wherein the electronic circuit system includes a battery, the electroniccircuit system configured to produce an indication associated with alife of the battery.
 23. The apparatus of claim 17, wherein theelectronics housing substantially surrounds the non-delivery end portionof the first medicament delivery device when the retention portionmatingly receives the non-delivery end portion.
 24. The apparatus ofclaim 17, wherein the electronics housing is distinct from the contactmember.
 25. The apparatus of claim 17, wherein the electronics housingis configured to surround a perimeter of the non-delivery end portionand extend along only the portion of the first medicament deliverydevice such that the contact member is spaced apart from the electronicshousing.
 26. The apparatus of claim 17, wherein the at least one of theswitch or the sensor is configured to produce an electronic signalassociated with at least one of a status of the first medicamentdelivery device within the electronics housing or the actuation of thefirst medicament delivery device.
 27. The apparatus of claim 26,wherein: the at least one of the switch or the sensor is a pressuresensor configured to produce the electronic signal in response to apressure exerted on the pressure sensor.
 28. A method, comprising:disposing a non-delivery end portion of a first medicament deliverydevice into an opening defined by an electronics housing, the firstmedicament delivery device including a medicament container and acontainer housing, a delivery end portion of the first medicamentdelivery device including a contact member coupled to the containerhousing and configured to contact a target location of a body during amedicament delivery event, the disposing performed such that the contactmember remains outside of the electronics housing before and duringactuation of the first medicament delivery device, the electronicshousing including an electronic circuit system, the electronic circuitsystem including at least one of a switch or a sensor coupled to theelectronics housing such that the at least one of the switch or thesensor remains spaced apart from the contact member during actuation ofthe first medicament delivery device, the electronic circuit systemincluding a light output device, and a wireless communications module,the electronic circuit system configured to produce a light output viathe light output device when the at least one of the switch or thesensor produces an electronic signal; manipulating the electronicshousing to cause the at least one of the switch or sensor to produce theelectronic signal; actuating the first medicament delivery device bymoving the electronics housing relative to the contact member causingthe medicament container to move within the container housing, theelectronic circuit system outputting, via the wireless communicationmodule, a compliance signal, the compliance signal being a short-rangeradio frequency signal including a time stamp associated with theactuation of the first medicament delivery device; removing the endportion of the first medicament delivery device from the electronicshousing; and disposing an end portion of a second medicament deliverydevice into the opening defined by the electronics housing.
 29. Themethod of claim 28, wherein the compliance signal has a frequencybetween approximately 2400 MHz and approximately 2480 MHz.
 30. Themethod of claim 28, wherein the first medicament delivery device is anyone of an autoinjector, a pen injector or an inhaler.
 31. The method ofclaim 28, further comprising: producing, from the electronic circuitsystem, a recorded speech output when the first medicament deliverydevice is actuated.
 32. The method of claim 28, further comprising:producing, from the electronic circuit system, a light output when thefirst medicament delivery device is actuated.
 33. The method of claim28, wherein the compliance signal includes any of a uniqueidentification of the electronics housing, an indicator associated witha validity of the medicament delivery event, or a location associatedwith the medicament delivery device.
 34. The method of claim 28, furthercomprising: outputting via the electronic circuit system an indicationassociated with a life of a battery.
 35. The method of claim 28, whereinthe wireless communication module includes at least one of amicroprocessor, a transmitter, a receiver, a transceiver, or a radiochipset.